Data / FDA device clearances / Radiology
FDA Radiology device clearances: 968 since Nov 2024
The full list. FDA radiology device clearances and approvals: 968 rows for $48.40, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 42 rows a month. The new rows come each week by email, $19 a month.
Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.
For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/panel/radiology, and every list with its row count and price is at https://specstream.ai/data/lists.json.
Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).
FDA made 968 device decisions in radiology (FDA review panel) from November 12, 2024 to October 30, 2026: 955 510(k) clearances and De Novo grants and 13 PMA approvals and supplements, for 487 applicants. The newest, K263109 on October 30, 2026, is EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100) from Ever Fortune.Ai, Co., Ltd..
The request: Every new FDA clearance or approval of a radiology device, with the applicant, its address and the product code. $10 of credit on sign-up, no card.
SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.
- 968Decisions
- 955510(k) and De Novo
- 13PMA
- October 30, 2026Latest decision
Newest decisions
The newest 100 of 968, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.
| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
|---|---|---|---|---|---|---|---|---|
| October 30, 2026 | K263109 | EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100) | Ever Fortune.Ai, Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | QAS | accessdata.fda.gov |
| October 30, 2026 | K261072 | DS Core Detect | Dentsply Sirona, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | MYN | accessdata.fda.gov |
| October 30, 2026 | K260575 | AutoGel Pad (400-046,400-005) | Top-Rank Health Care Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | MUI | accessdata.fda.gov |
| October 29, 2026 | K263648 | Vitrea Advanced Visualization, Version 7.16 | Canon Medical Informatics, Inc. | Minnesota | Substantially Equivalent | 510(k) special | LLZ | accessdata.fda.gov |
| October 28, 2026 | K261676 | uPMR Zenith | Shanghai United Imaging Healthcare Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OUO | accessdata.fda.gov |
| October 28, 2026 | K261648 | Evident Vascular Guidance System | Evident Vascular, Inc. | California | Substantially Equivalent | 510(k) traditional | IYO | accessdata.fda.gov |
| October 27, 2026 | K261512 | OsteoSight Spine (v1) | Naitive Technologies, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | SAO | accessdata.fda.gov |
| October 26, 2026 | K261763 | MIM KineticID | Mim Software, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| October 23, 2026 | K262080 | OTOPLAN | Cascination AG | Switzerland | Substantially Equivalent | 510(k) traditional | QQE | accessdata.fda.gov |
| October 23, 2026 | K261679 | BlineSlide | Deep Breathe, Inc. | Canada | Substantially Equivalent | 510(k) traditional | POK | accessdata.fda.gov |
| October 21, 2026 | K261788 | Eden PACS | Higia., Inc. d/b/a Eden | Delaware | Substantially Equivalent | 510(k) abbreviated | LLZ | accessdata.fda.gov |
| October 21, 2026 | K261531 | PV-iCurve Pro | Perception Vision Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| October 20, 2026 | K262093 | Accuro XV | Rivanna Medical, Inc. | Virginia | Substantially Equivalent | 510(k) traditional | IYO | accessdata.fda.gov |
| October 20, 2026 | K262062 | CINA-Aneurysm | Avicenna.Ai | France | Substantially Equivalent | 510(k) traditional | QBS | accessdata.fda.gov |
| October 19, 2026 | K262147 | CINA-Aneurysm+ | Avicenna.Ai | France | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| October 19, 2026 | K260510 | VenusCT | Linatech, LLC | California | Substantially Equivalent | 510(k) traditional | SFV | accessdata.fda.gov |
| October 16, 2026 | K261585 | Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound... | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IYN | accessdata.fda.gov |
| October 16, 2026 | K260605 | Lilium one (USM330) | Lilium Otsuka Co., Ltd. | Japan | Substantially Equivalent | 510(k) traditional | IYO | accessdata.fda.gov |
| October 16, 2026 | K260391 | AVIEW Aorta Metrics | Coreline Soft Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | JAK | accessdata.fda.gov |
| October 15, 2026 | K261616 | Single-Use EBUS Balloon | Micro-Tech (Nanjing) Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | PSV | accessdata.fda.gov |
| October 13, 2026 | P200029/S015 | TheraSphere Y-90 Glass Microspheres System | Boston Scientific Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | NAW | accessdata.fda.gov |
| October 9, 2026 | K262902 | ECHELON Synergy | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | LNH | accessdata.fda.gov |
| October 9, 2026 | K262301 | Rapid ICH (v4.0) | Ischemaview, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | QAS | accessdata.fda.gov |
| October 8, 2026 | K263150 | V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10... | Samsung Medison Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | IYN | accessdata.fda.gov |
| October 8, 2026 | K261617 | Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic... | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IYN | accessdata.fda.gov |
| October 7, 2026 | K262134 | NeuroDR | Deep Reasoning Ai, Inc. | Florida | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| October 7, 2026 | K261733 | Ligence Heart | UAB Ligence | Lithuania | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| October 7, 2026 | K260092 | Vista AI Scan | Vista AI, Inc. | California | Substantially Equivalent | 510(k) traditional | LNH | accessdata.fda.gov |
| October 5, 2026 | K262813 | InkSpace Imaging Small Body Array (SBA12PH15x) | Inkspace Imaging, Inc. | California | Substantially Equivalent | 510(k) special | MOS | accessdata.fda.gov |
| October 5, 2026 | K261655 | RT Elements (4.6) | Brainlab SE | Germany | Substantially Equivalent | 510(k) traditional | MUJ | accessdata.fda.gov |
| October 5, 2026 | K260523 | QGuideCT (1.0) | Medis Medical Imaging Systems BV | Netherlands | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| October 2, 2026 | K262985 | Medical Monitor (32MD08WC) | Lg Electronics.Inc | South Korea | Substantially Equivalent | 510(k) traditional | PGY | accessdata.fda.gov |
| October 2, 2026 | K262412 | Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) | Barco NV | Belgium | Substantially Equivalent | 510(k) special | PGY | accessdata.fda.gov |
| October 2, 2026 | K261943 | REMEX-T(K)100C | Remedi, Inc. | South Korea | Substantially Equivalent | 510(k) traditional | IZL | accessdata.fda.gov |
| October 2, 2026 | K261933 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | Wisconsin | Substantially Equivalent | 510(k) traditional | IYN | accessdata.fda.gov |
| October 2, 2026 | K261042 | Lung Guidance | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Wisconsin | Substantially Equivalent | 510(k) traditional | QJU | accessdata.fda.gov |
| October 1, 2026 | K261612 | SwiftSight-BodyComposition | Airs Medical, Inc. | South Korea | Substantially Equivalent | 510(k) traditional | LNH | accessdata.fda.gov |
| September 30, 2026 | K263033 | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) | Fussen Technology Co., Ltd. | China | Substantially Equivalent | 510(k) special | OAS | accessdata.fda.gov |
| September 29, 2026 | K263048 | Syngo Carbon Space (VA4) | Siemens Healthineers AG | Germany | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| September 29, 2026 | K261225 | CAS-One IR | Cascination AG | Switzerland | Substantially Equivalent | 510(k) traditional | JAK | accessdata.fda.gov |
| September 25, 2026 | K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound... | Samsung Medison Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | IYN | accessdata.fda.gov |
| September 25, 2026 | K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | IYN | accessdata.fda.gov |
| September 25, 2026 | K260055 | syngo.CT Brain Quantification | Siemens Medical Solutions USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| September 24, 2026 | K260313 | MD-6000S Bladder Scanner | MEDA Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IYO | accessdata.fda.gov |
| September 24, 2026 | K260114 | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | Iowa | Substantially Equivalent | 510(k) traditional | ITX | accessdata.fda.gov |
| September 23, 2026 | K261874 | Syneris PACS v.1.0.1.0 | Syneris | Canada | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| September 23, 2026 | K260597 | VIRTUE QA | ProNova Solutions | Tennessee | Substantially Equivalent | 510(k) traditional | LHN | accessdata.fda.gov |
| September 22, 2026 | K262442 | HipStudio Analysis | Replasia BV | Belgium | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| September 22, 2026 | K262390 | BoneXpert | Visiana | Denmark | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| September 22, 2026 | K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Samsung HME America, Inc., dba NeuroLogica Corp. | Massachusetts | Substantially Equivalent | 510(k) traditional | JAK | accessdata.fda.gov |
| September 21, 2026 | K261368 | Rapid Platform (R6.7) | Ischemaview, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| September 18, 2026 | K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| September 18, 2026 | K261229 | SCENARIA View Phase 6.0 | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | JAK | accessdata.fda.gov |
| September 16, 2026 | K261865 | AerFrame Alignment Laser Box (LBV2) | Stabilix, LLC | Texas | Substantially Equivalent | 510(k) traditional | IYE | accessdata.fda.gov |
| September 16, 2026 | K261758 | Embrace Vision Neonatal MRI System | Aspect Imaging, Ltd. | Israel | Substantially Equivalent | 510(k) traditional | LNH | accessdata.fda.gov |
| September 16, 2026 | K261623 | EchoPAC Software Only / EchoPAC Plug-in (v211) | GE Medical Systems Ultrasound and Primary Care Diagnostics | Wisconsin | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| September 16, 2026 | K261283 | APERTO Lucent MRI System | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | LNH | accessdata.fda.gov |
| September 16, 2026 | K260906 | a2z-Abdo-Triage | A2z Radiology Ai, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | QAS | accessdata.fda.gov |
| September 15, 2026 | K261861 | SPINEsim v1.0 | Mdsim S.A. | Luxembourg | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| September 15, 2026 | K261677 | Artificial Intelligence Renal Assessment (AIRA) Version 1 | Aramis Global AI Consultancies, LLC | United Arab Emirates | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| September 15, 2026 | K254214 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| September 14, 2026 | K261517 | qCT Lung (v1.0) | Qure.Ai Technologies Pvt. , Ltd. | India | Substantially Equivalent | 510(k) traditional | QDQ | accessdata.fda.gov |
| September 11, 2026 | K262151 | SpaceOAR Flex System | Boston Scientific Corporation | Massachusetts | Substantially Equivalent | 510(k) traditional | OVB | accessdata.fda.gov |
| September 11, 2026 | K261305 | MICSI-PET | Microstructure Imaging, Inc. | New York | Substantially Equivalent | 510(k) traditional | KPS | accessdata.fda.gov |
| September 11, 2026 | K254072 | BoneVue | Curvebeam AI / Curvebeam, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | KGI | accessdata.fda.gov |
| September 10, 2026 | K261795 | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | Australia | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| September 10, 2026 | K260879 | 4DM | Invia, LLC | Michigan | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| September 9, 2026 | K252486 | ChestView US (1.1) | Gleamer | France | Substantially Equivalent | 510(k) traditional | MYN | accessdata.fda.gov |
| September 9, 2026 | K251417 | ReVISION 2 | Argus Cognitive, Inc. | New Hampshire | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| September 8, 2026 | K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS... | DRTECH Corporation | South Korea | Substantially Equivalent | 510(k) traditional | KPR | accessdata.fda.gov |
| September 4, 2026 | K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | Maryland | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| September 4, 2026 | K260525 | NextMR Spine | MRI2CT, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| September 4, 2026 | K253836 | FCT iStream Phase 2 | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | JAK | accessdata.fda.gov |
| September 2, 2026 | K261313 | Vivid Explorer/Vivid Advanced/Vivid Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | Wisconsin | Substantially Equivalent | 510(k) traditional | IYN | accessdata.fda.gov |
| September 2, 2026 | K254090 | I-View® | Hologic, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | MUE | accessdata.fda.gov |
| September 1, 2026 | K262783 | RadiForce MX247W | Eizo Corporation | Japan | Substantially Equivalent | 510(k) abbreviated | PGY | accessdata.fda.gov |
| September 1, 2026 | K260758 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | China | Substantially Equivalent | 510(k) traditional | LNH | accessdata.fda.gov |
| August 31, 2026 | K261718 | EZFluence (RADEZ V2) | Radformation, Inc. | New York | Substantially Equivalent | 510(k) traditional | IYE | accessdata.fda.gov |
| August 31, 2026 | K260488 | MULTIX Impact; MULTIX Impact C | Siemens Medical Solutions USA, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | KPR | accessdata.fda.gov |
| August 28, 2026 | K261378 | Rayvolve AZchest | AZmed | France | Substantially Equivalent | 510(k) traditional | QBS | accessdata.fda.gov |
| August 27, 2026 | K260481 | GC85A | Samsung Electronics Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | KPR | accessdata.fda.gov |
| August 27, 2026 | K260401 | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | PSV | accessdata.fda.gov |
| August 26, 2026 | K260811 | Heartvue.Proton | Heartvue.ai, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| August 26, 2026 | K260733 | MRIA Radiation Therapy Information System (MRIA) | Manteia Technologies Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | IYE | accessdata.fda.gov |
| August 25, 2026 | K261595 | Ceevra Reveal 4 | Ceevra, Inc. | California | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| August 24, 2026 | K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90... | Sonoscape Medical Corp. | China | Substantially Equivalent | 510(k) traditional | IYN | accessdata.fda.gov |
| August 21, 2026 | P200029/S014 | TheraSphere | Boston Scientific Corporation | Massachusetts | Approved | PMA 180-day supplement | NAW | accessdata.fda.gov |
| August 21, 2026 | K262127 | DS Core CBCT Anatomy | Dentsply Sirona | Pennsylvania | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| August 21, 2026 | K260584 | BoneMRI | Mriguidance B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| August 21, 2026 | K253726 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OWB | accessdata.fda.gov |
| August 19, 2026 | K262622 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | Connecticut | Substantially Equivalent | 510(k) special | LNH | accessdata.fda.gov |
| August 19, 2026 | K261413 | EXTRON 3;EXTRON 6 | DRTECH Corporation | South Korea | Substantially Equivalent | 510(k) traditional | OWB | accessdata.fda.gov |
| August 18, 2026 | K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | California | Substantially Equivalent | 510(k) traditional | QIH | accessdata.fda.gov |
| August 17, 2026 | K261500 | KBA3D (v2.4.0) | S.m.a.i.o | France | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| August 17, 2026 | K254250 | MagicScan-1.5, GreenMR Serenity 1.5T | Xingaoyi Medical Equipment Co.,Ltd | China | Substantially Equivalent | 510(k) traditional | LNH | accessdata.fda.gov |
| August 14, 2026 | K262452 | AutoContour (RADAC V6) | Radformation, Inc. | New York | Substantially Equivalent | 510(k) special | QKB | accessdata.fda.gov |
| August 14, 2026 | K262449 | AdvaView | Advahealth Solutions, LLC | Delaware | Substantially Equivalent | 510(k) special | LLZ | accessdata.fda.gov |
| August 14, 2026 | K260898 | Transpara (2.1.0) | Screenpoint Medical B.V. | Netherlands | Substantially Equivalent | 510(k) special | QDQ | accessdata.fda.gov |
| August 13, 2026 | K253808 | AIR Recon DL | GE Medical Systems | Wisconsin | Substantially Equivalent | 510(k) traditional | LNH | accessdata.fda.gov |
| August 12, 2026 | K261916 | NeuroQuant PET | Cortechs Labs, Inc. | California | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
Applicants with the most decisions
| Applicant | Decisions | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 29 | September 25, 2026 |
| Shanghai United Imaging Healthcare Co., Ltd. | 26 | October 28, 2026 |
| Philips Ultrasound, LLC | 20 | September 25, 2026 |
| GE Medical Systems Ultrasound and Primary Care Diagnostics | 18 | September 16, 2026 |
| Canon Medical Systems Corporation | 15 | May 20, 2026 |
| Philips Medical Systems Nederland B.V. | 14 | August 7, 2026 |
| Varian Medical Systems, Inc. | 14 | August 3, 2026 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 12 | October 16, 2026 |
| Fujifilm Corporation | 11 | October 9, 2026 |
| Boston Scientific Corporation | 10 | October 13, 2026 |
| Ge Medical Systems, LLC | 10 | June 24, 2026 |
| Siemens Healthcare GmbH | 10 | June 16, 2026 |
| Samsung Medison Co., Ltd. | 9 | October 8, 2026 |
| Aidoc Medical , Ltd. | 9 | May 14, 2026 |
| Ischemaview, Inc. | 7 | October 9, 2026 |
| Radformation, Inc. | 7 | August 31, 2026 |
| Esaote, S.p.A. | 7 | July 31, 2026 |
| Varian Medical Systems | 7 | July 10, 2026 |
| DeepHealth, Inc. | 7 | June 15, 2026 |
| Pearl, Inc. | 7 | November 14, 2025 |
By decision type
| Decision type | Decisions | Latest |
|---|---|---|
| 510(k) traditional | 836 | October 30, 2026 |
| 510(k) special | 104 | October 29, 2026 |
| 510(k) abbreviated | 12 | October 21, 2026 |
| PMA 180-day supplement | 6 | August 21, 2026 |
| PMA 30-day notice | 5 | October 13, 2026 |
| De Novo | 3 | February 11, 2026 |
| PMA panel track supplement | 2 | February 10, 2026 |
By state or country
| State or country | Decisions | Latest |
|---|---|---|
| China | 114 | October 30, 2026 |
| California | 88 | October 28, 2026 |
| South Korea | 85 | October 16, 2026 |
| France | 55 | October 20, 2026 |
| Massachusetts | 47 | October 13, 2026 |
| Japan | 42 | October 16, 2026 |
| Wisconsin | 40 | October 2, 2026 |
| Israel | 40 | September 16, 2026 |
| Germany | 39 | October 5, 2026 |
| Washington | 35 | September 25, 2026 |
| Netherlands | 31 | October 5, 2026 |
| Pennsylvania | 21 | October 30, 2026 |
| United Kingdom | 21 | October 27, 2026 |
| Canada | 21 | October 23, 2026 |
| Taiwan | 20 | October 30, 2026 |
| Colorado | 19 | October 9, 2026 |
| New York | 19 | September 11, 2026 |
| Italy | 15 | August 4, 2026 |
| Tennessee | 14 | September 25, 2026 |
| Texas | 13 | September 16, 2026 |
| Australia | 13 | September 10, 2026 |
| Sweden | 13 | July 31, 2026 |
| Florida | 11 | October 7, 2026 |
| Ohio | 10 | October 26, 2026 |
| Switzerland | 10 | October 23, 2026 |
Where FDA publishes these decisions
CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.