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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 dateNumberDeviceApplicantLocationDecisionTypeProduct codeSource
October 30, 2026K263109EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)Ever Fortune.Ai, Co., Ltd.TaiwanSubstantially Equivalent510(k) traditionalQASaccessdata.fda.gov
October 30, 2026K261072DS Core DetectDentsply Sirona, Inc.PennsylvaniaSubstantially Equivalent510(k) traditionalMYNaccessdata.fda.gov
October 30, 2026K260575AutoGel Pad (400-046,400-005)Top-Rank Health Care Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalMUIaccessdata.fda.gov
October 29, 2026K263648Vitrea Advanced Visualization, Version 7.16Canon Medical Informatics, Inc.MinnesotaSubstantially Equivalent510(k) specialLLZaccessdata.fda.gov
October 28, 2026K261676uPMR ZenithShanghai United Imaging Healthcare Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalOUOaccessdata.fda.gov
October 28, 2026K261648Evident Vascular™ Guidance SystemEvident Vascular, Inc.CaliforniaSubstantially Equivalent510(k) traditionalIYOaccessdata.fda.gov
October 27, 2026K261512OsteoSight Spine (v1)Naitive Technologies, Ltd.United KingdomSubstantially Equivalent510(k) traditionalSAOaccessdata.fda.gov
October 26, 2026K261763MIM – KineticIDMim Software, Inc.OhioSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
October 23, 2026K262080OTOPLANCascination AGSwitzerlandSubstantially Equivalent510(k) traditionalQQEaccessdata.fda.gov
October 23, 2026K261679BlineSlideDeep Breathe, Inc.CanadaSubstantially Equivalent510(k) traditionalPOKaccessdata.fda.gov
October 21, 2026K261788Eden PACSHigia., Inc. d/b/a EdenDelawareSubstantially Equivalent510(k) abbreviatedLLZaccessdata.fda.gov
October 21, 2026K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
October 20, 2026K262093Accuro XVRivanna Medical, Inc.VirginiaSubstantially Equivalent510(k) traditionalIYOaccessdata.fda.gov
October 20, 2026K262062CINA-AneurysmAvicenna.AiFranceSubstantially Equivalent510(k) traditionalQBSaccessdata.fda.gov
October 19, 2026K262147CINA-Aneurysm+Avicenna.AiFranceSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
October 19, 2026K260510VenusCTLinatech, LLCCaliforniaSubstantially Equivalent510(k) traditionalSFVaccessdata.fda.gov
October 16, 2026K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound...Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
October 16, 2026K260605Lilium one (USM330)Lilium Otsuka Co., Ltd.JapanSubstantially Equivalent510(k) traditionalIYOaccessdata.fda.gov
October 16, 2026K260391AVIEW Aorta MetricsCoreline Soft Co., Ltd.South KoreaSubstantially Equivalent510(k) traditionalJAKaccessdata.fda.gov
October 15, 2026K261616Single-Use EBUS BalloonMicro-Tech (Nanjing) Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalPSVaccessdata.fda.gov
October 13, 2026P200029/S015TheraSphere™ Y-90 Glass Microspheres SystemBoston Scientific CorporationMassachusetts30-day notice acceptedPMA 30-day noticeNAWaccessdata.fda.gov
October 9, 2026K262902ECHELON SynergyFujifilm CorporationJapanSubstantially Equivalent510(k) traditionalLNHaccessdata.fda.gov
October 9, 2026K262301Rapid ICH (v4.0)Ischemaview, Inc.ColoradoSubstantially Equivalent510(k) traditionalQASaccessdata.fda.gov
October 8, 2026K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10...Samsung Medison Co., Ltd.South KoreaSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
October 8, 2026K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic...Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
October 7, 2026K262134NeuroDRDeep Reasoning Ai, Inc.FloridaSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
October 7, 2026K261733Ligence HeartUAB LigenceLithuaniaSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
October 7, 2026K260092Vista AI ScanVista AI, Inc.CaliforniaSubstantially Equivalent510(k) traditionalLNHaccessdata.fda.gov
October 5, 2026K262813InkSpace Imaging Small Body Array (SBA12PH15x)Inkspace Imaging, Inc.CaliforniaSubstantially Equivalent510(k) specialMOSaccessdata.fda.gov
October 5, 2026K261655RT Elements (4.6)Brainlab SEGermanySubstantially Equivalent510(k) traditionalMUJaccessdata.fda.gov
October 5, 2026K260523QGuideCT (1.0)Medis Medical Imaging Systems BVNetherlandsSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
October 2, 2026K262985Medical Monitor (32MD08WC)Lg Electronics.IncSouth KoreaSubstantially Equivalent510(k) traditionalPGYaccessdata.fda.gov
October 2, 2026K262412Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)Barco NVBelgiumSubstantially Equivalent510(k) specialPGYaccessdata.fda.gov
October 2, 2026K261943REMEX-T(K)100CRemedi, Inc.South KoreaSubstantially Equivalent510(k) traditionalIZLaccessdata.fda.gov
October 2, 2026K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLCWisconsinSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
October 2, 2026K261042Lung GuidanceGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCWisconsinSubstantially Equivalent510(k) traditionalQJUaccessdata.fda.gov
October 1, 2026K261612SwiftSight-BodyCompositionAirs Medical, Inc.South KoreaSubstantially Equivalent510(k) traditionalLNHaccessdata.fda.gov
September 30, 2026K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)Fussen Technology Co., Ltd.ChinaSubstantially Equivalent510(k) specialOASaccessdata.fda.gov
September 29, 2026K263048Syngo Carbon Space (VA4)Siemens Healthineers AGGermanySubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
September 29, 2026K261225CAS-One IRCascination AGSwitzerlandSubstantially Equivalent510(k) traditionalJAKaccessdata.fda.gov
September 25, 2026K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound...Samsung Medison Co., Ltd.South KoreaSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
September 25, 2026K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
September 25, 2026K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc.TennesseeSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
September 24, 2026K260313MD-6000S Bladder ScannerMEDA Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalIYOaccessdata.fda.gov
September 24, 2026K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.IowaSubstantially Equivalent510(k) traditionalITXaccessdata.fda.gov
September 23, 2026K261874Syneris PACS v.1.0.1.0SynerisCanadaSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
September 23, 2026K260597VIRTUE QAProNova SolutionsTennesseeSubstantially Equivalent510(k) traditionalLHNaccessdata.fda.gov
September 22, 2026K262442HipStudio AnalysisReplasia BVBelgiumSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
September 22, 2026K262390BoneXpertVisianaDenmarkSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
September 22, 2026K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.MassachusettsSubstantially Equivalent510(k) traditionalJAKaccessdata.fda.gov
September 21, 2026K261368Rapid Platform (R6.7)Ischemaview, Inc.ColoradoSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
September 18, 2026K261855Elucid PlaqueIQElucid Bioimaging, Inc.MassachusettsSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
September 18, 2026K261229SCENARIA View Phase 6.0Fujifilm CorporationJapanSubstantially Equivalent510(k) traditionalJAKaccessdata.fda.gov
September 16, 2026K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCTexasSubstantially Equivalent510(k) traditionalIYEaccessdata.fda.gov
September 16, 2026K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.IsraelSubstantially Equivalent510(k) traditionalLNHaccessdata.fda.gov
September 16, 2026K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care DiagnosticsWisconsinSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
September 16, 2026K261283APERTO Lucent MRI SystemFujifilm CorporationJapanSubstantially Equivalent510(k) traditionalLNHaccessdata.fda.gov
September 16, 2026K260906a2z-Abdo-TriageA2z Radiology Ai, Inc.MassachusettsSubstantially Equivalent510(k) traditionalQASaccessdata.fda.gov
September 15, 2026K261861SPINEsim v1.0Mdsim S.A.LuxembourgSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
September 15, 2026K261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLCUnited Arab EmiratesSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
September 15, 2026K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.TaiwanSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
September 14, 2026K261517qCT Lung (v1.0)Qure.Ai Technologies Pvt. , Ltd.IndiaSubstantially Equivalent510(k) traditionalQDQaccessdata.fda.gov
September 11, 2026K262151SpaceOAR Flex™ SystemBoston Scientific CorporationMassachusettsSubstantially Equivalent510(k) traditionalOVBaccessdata.fda.gov
September 11, 2026K261305MICSI-PETMicrostructure Imaging, Inc.New YorkSubstantially Equivalent510(k) traditionalKPSaccessdata.fda.gov
September 11, 2026K254072BoneVueCurvebeam AI / Curvebeam, LLCPennsylvaniaSubstantially Equivalent510(k) traditionalKGIaccessdata.fda.gov
September 10, 2026K261795Quicktome Software SuiteOmniscient Neurotechnology Pty, Ltd.AustraliaSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
September 10, 2026K2608794DMInvia, LLCMichiganSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
September 9, 2026K252486ChestView US (1.1)GleamerFranceSubstantially Equivalent510(k) traditionalMYNaccessdata.fda.gov
September 9, 2026K251417ReVISION 2Argus Cognitive, Inc.New HampshireSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
September 8, 2026K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS...DRTECH CorporationSouth KoreaSubstantially Equivalent510(k) traditionalKPRaccessdata.fda.gov
September 4, 2026K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLCMarylandSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
September 4, 2026K260525NextMR SpineMRI2CT, Inc.DelawareSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
September 4, 2026K253836FCT iStream Phase 2Fujifilm CorporationJapanSubstantially Equivalent510(k) traditionalJAKaccessdata.fda.gov
September 2, 2026K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsWisconsinSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
September 2, 2026K254090I-View®Hologic, Inc.DelawareSubstantially Equivalent510(k) traditionalMUEaccessdata.fda.gov
September 1, 2026K262783RadiForce MX247WEizo CorporationJapanSubstantially Equivalent510(k) abbreviatedPGYaccessdata.fda.gov
September 1, 2026K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.ChinaSubstantially Equivalent510(k) traditionalLNHaccessdata.fda.gov
August 31, 2026K261718EZFluence (RADEZ V2)Radformation, Inc.New YorkSubstantially Equivalent510(k) traditionalIYEaccessdata.fda.gov
August 31, 2026K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.PennsylvaniaSubstantially Equivalent510(k) traditionalKPRaccessdata.fda.gov
August 28, 2026K261378Rayvolve AZchestAZmedFranceSubstantially Equivalent510(k) traditionalQBSaccessdata.fda.gov
August 27, 2026K260481GC85ASamsung Electronics Co., Ltd.South KoreaSubstantially Equivalent510(k) traditionalKPRaccessdata.fda.gov
August 27, 2026K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)Olympus Medical Systems CorporationJapanSubstantially Equivalent510(k) traditionalPSVaccessdata.fda.gov
August 26, 2026K260811Heartvue.ProtonHeartvue.ai, Inc.TennesseeSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
August 26, 2026K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalIYEaccessdata.fda.gov
August 25, 2026K261595Ceevra Reveal 4Ceevra, Inc.CaliforniaSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
August 24, 2026K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90...Sonoscape Medical Corp.ChinaSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
August 21, 2026P200029/S014TheraSphereBoston Scientific CorporationMassachusettsApprovedPMA 180-day supplementNAWaccessdata.fda.gov
August 21, 2026K262127DS Core CBCT AnatomyDentsply SironaPennsylvaniaSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
August 21, 2026K260584BoneMRIMriguidance B.V.NetherlandsSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
August 21, 2026K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalOWBaccessdata.fda.gov
August 19, 2026K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.ConnecticutSubstantially Equivalent510(k) specialLNHaccessdata.fda.gov
August 19, 2026K261413EXTRON 3;EXTRON 6DRTECH CorporationSouth KoreaSubstantially Equivalent510(k) traditionalOWBaccessdata.fda.gov
August 18, 2026K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.CaliforniaSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
August 17, 2026K261500KBA3D (v2.4.0)S.m.a.i.oFranceSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
August 17, 2026K254250MagicScan-1.5, GreenMR Serenity 1.5TXingaoyi Medical Equipment Co.,LtdChinaSubstantially Equivalent510(k) traditionalLNHaccessdata.fda.gov
August 14, 2026K262452AutoContour (RADAC V6)Radformation, Inc.New YorkSubstantially Equivalent510(k) specialQKBaccessdata.fda.gov
August 14, 2026K262449AdvaViewAdvahealth Solutions, LLCDelawareSubstantially Equivalent510(k) specialLLZaccessdata.fda.gov
August 14, 2026K260898Transpara (2.1.0)Screenpoint Medical B.V.NetherlandsSubstantially Equivalent510(k) specialQDQaccessdata.fda.gov
August 13, 2026K253808AIR Recon DLGE Medical SystemsWisconsinSubstantially Equivalent510(k) traditionalLNHaccessdata.fda.gov
August 12, 2026K261916NeuroQuant PETCortechs Labs, Inc.CaliforniaSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Siemens Medical Solutions USA, Inc.29September 25, 2026
Shanghai United Imaging Healthcare Co., Ltd.26October 28, 2026
Philips Ultrasound, LLC20September 25, 2026
GE Medical Systems Ultrasound and Primary Care Diagnostics18September 16, 2026
Canon Medical Systems Corporation15May 20, 2026
Philips Medical Systems Nederland B.V.14August 7, 2026
Varian Medical Systems, Inc.14August 3, 2026
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.12October 16, 2026
Fujifilm Corporation11October 9, 2026
Boston Scientific Corporation10October 13, 2026
Ge Medical Systems, LLC10June 24, 2026
Siemens Healthcare GmbH10June 16, 2026
Samsung Medison Co., Ltd.9October 8, 2026
Aidoc Medical , Ltd.9May 14, 2026
Ischemaview, Inc.7October 9, 2026
Radformation, Inc.7August 31, 2026
Esaote, S.p.A.7July 31, 2026
Varian Medical Systems7July 10, 2026
DeepHealth, Inc.7June 15, 2026
Pearl, Inc.7November 14, 2025

By decision type

Decision typeDecisionsLatest
510(k) traditional836October 30, 2026
510(k) special104October 29, 2026
510(k) abbreviated12October 21, 2026
PMA 180-day supplement6August 21, 2026
PMA 30-day notice5October 13, 2026
De Novo3February 11, 2026
PMA panel track supplement2February 10, 2026

By state or country

State or countryDecisionsLatest
China114October 30, 2026
California88October 28, 2026
South Korea85October 16, 2026
France55October 20, 2026
Massachusetts47October 13, 2026
Japan42October 16, 2026
Wisconsin40October 2, 2026
Israel40September 16, 2026
Germany39October 5, 2026
Washington35September 25, 2026
Netherlands31October 5, 2026
Pennsylvania21October 30, 2026
United Kingdom21October 27, 2026
Canada21October 23, 2026
Taiwan20October 30, 2026
Colorado19October 9, 2026
New York19September 11, 2026
Italy15August 4, 2026
Tennessee14September 25, 2026
Texas13September 16, 2026
Australia13September 10, 2026
Sweden13July 31, 2026
Florida11October 7, 2026
Ohio10October 26, 2026
Switzerland10October 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.