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Data / Medical devices / Germany / Siemens Healthineers AG

Siemens Healthineers AG: FDA-registered device maker in FORCHHEIM Bavaria, Germany, 290 510(k) clearances and 1 PMA approval

Siemens Healthineers AG is registered with the FDA (registration 3004977335) in FORCHHEIM Bavaria, Germany. It lists 45 device types. The FDA files 290 510(k) clearances and 1 PMA approval under its listings, the newest dated September 25, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Siemens Healthineers AG
FDA registration number
3004977335
Address
SIEMENSSTRASSE 1 -OR- Rittigfeld 1, FORCHHEIM Bavaria, Germany, 91301
Owner or operator
Siemens Healthineers AG (8010024)
Roles
Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed
March 26, 2003
Registered through
2027
Brand names listed
3D CT Reconstruction Software, 3D-ANGIO, ADMIRE, ADMIRE Quantitative Dose Reduction, AI Rad Companion (Musculoskeletal), AI-Rad Companion (Cardiovascular), AI-Rad Companion (Engine), AI-Rad Companion (Pulmonary) and more

Devices it lists

DeviceProduct codeClassRoleSource
Alarm, Blood-PressureDSJ2Manufactureraccessdata.fda.gov
Amplifier And Signal Conditioner, Transducer SignalDRQ2Manufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Manufactureraccessdata.fda.gov
Assembly, Tube Housing, X-Ray, DiagnosticITY1Manufacturer, Specification developeraccessdata.fda.gov
Automated Radiological Image Processing SoftwareQIH2Manufactureraccessdata.fda.gov
Bone SonometerMUA2Exporter to the USaccessdata.fda.gov
Camera, Multi Format, RadiologicalLMC2Exporter to the USaccessdata.fda.gov
Cassette, Radiographic FilmIXA2Exporter to the USaccessdata.fda.gov
Coil, Magnetic Resonance, SpecialtyMOS2Exporter to the USaccessdata.fda.gov
Colon Computed Tomography System, Computer Aided DetectionNWE2Manufactureraccessdata.fda.gov
Computer, Blood-PressureDSK2Exporter to the US, Manufactureraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the US, Manufactureraccessdata.fda.gov
Densitometer, BoneKGI2Manufactureraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Exporter to the USaccessdata.fda.gov
Digital Breast TomosynthesisOTE3Manufactureraccessdata.fda.gov
Full Field Digital, System, X-Ray, MammographicMUE2Manufactureraccessdata.fda.gov
Generator, High-Voltage, X-Ray, DiagnosticIZO1Manufactureraccessdata.fda.gov
Holder, Film, X-RayEGZ1Exporter to the USaccessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, MobileOXO2Manufacturer, Specification developeraccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Lithotriptor, Extracorporeal Shock-Wave, UrologicalLNS2Exporter to the US, Manufactureraccessdata.fda.gov
Lung Computed Tomography System, Computer-Aided DetectionOEB2Manufactureraccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Exporter to the USaccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Exporter to the USaccessdata.fda.gov
Monitor, St Segment With AlarmMLD2Exporter to the USaccessdata.fda.gov
OximeterDQA2Exporter to the US, Manufactureraccessdata.fda.gov
Probe, ThermodilutionKRB2Manufactureraccessdata.fda.gov
Radiological Computer-Assisted Triage And Notification SoftwareQAS2Manufactureraccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Exporter to the USaccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Exporter to the US, Manufactureraccessdata.fda.gov
System, Nuclear Magnetic Resonance ImagingLNH2Complaint file establishment, Manufactureraccessdata.fda.gov
System, Planning, Radiation Therapy TreatmentMUJ2Manufactureraccessdata.fda.gov
System, Radiation Therapy, Charged-Particle, MedicalLHN2Exporter to the USaccessdata.fda.gov
System, X-Ray, AngiographicIZI2Exporter to the US, Manufactureraccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Complaint file establishment, Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
System, X-Ray, MammographicIZH2Complaint file establishmentaccessdata.fda.gov
System, X-Ray, MobileIZL2Specification developeraccessdata.fda.gov
System, X-Ray, StationaryKPR2Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
System, X-Ray, Tomography, ComputedJAK2Complaint file establishment, Manufactureraccessdata.fda.gov
Table, Radiographic, Non-Tilting, PoweredIZZ2Complaint file establishmentaccessdata.fda.gov
Table, Radiographic, TiltingIXR2Complaint file establishmentaccessdata.fda.gov
Ultrasonic Body Composition AnalyzerOMV2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 290.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 25, 2026K260055syngo.CT Brain QuantificationQIHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
June 25, 2026K253786syngo.CT Coronary CockpitQIHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
June 18, 2026K253678MAMMOMAT B.brilliant (11372950)MUESubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
April 29, 2026K254184syngo Application SoftwareQIHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
April 24, 2026K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
April 23, 2026K253752ARTIS genio floor; ARTIS icono.explore floorOWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 20, 2026K253574SOMATOM X.cite; SOMATOM X.ceedJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
November 20, 2025K253495syngo.MR Applications (VB80)LLZSubstantially EquivalentSiemens Healthineers AGaccessdata.fda.gov
October 24, 2025K251059Syngo Carbon Clinicals (VA41)QIHSubstantially EquivalentSiemens Healthineers AGaccessdata.fda.gov
October 15, 2025K251805syngo.CT Dual EnergyJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 31, 2025K250738YSIO X.preeKPRSubstantially EquivalentSiemens Medical Solutionsaccessdata.fda.gov
July 29, 2025K251523Cios SpinOWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 28, 2025K251061NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 14, 2025K250660LUMINOS Q.namix T; LUMINOS Q.namix ROWBSubstantially EquivalentSiemens Medical Solutionsaccessdata.fda.gov
July 9, 2025K251520Cios Alpha; Cios FlowOWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 3, 2025K250822SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.PulseJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
April 10, 2025K243145syngo.CT LVO DetectionQASSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
February 12, 2025K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
January 3, 2025K241757syngo.CT Dual EnergyJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 22, 2024K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)OWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 11, 2024K241569syngo Application SoftwareLLZSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
September 3, 2024K241295SOMATOM On.siteJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
May 23, 2024K240294Syngo Carbon Enterprise Access (VA40A)LLZSubstantially EquivalentSiemens Healthcare GmbHaccessdata.fda.gov
May 21, 2024K233543YSIO X.preeKPRSubstantially EquivalentSiemens Medical Solutionsaccessdata.fda.gov
May 9, 2024K232976VUZE SystemLLZSubstantially EquivalentVuze Medical , Ltd.accessdata.fda.gov
April 26, 2024K232799syngo.via RT Image SuiteMUJSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 28, 2024K233657NAEOTOM AlphaJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 27, 2024K233539MAMMOMAT B.brilliantMUESubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 26, 2024K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceedJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 22, 2024K232431syngo.CT Brain HemorrhageQASSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 15, 2024K233748CIARTIC Move (VB10)OWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
January 4, 2024K232136syngo.CT ApplicationsJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
December 21, 2023K232744syngo Virtual Cockpit (VB10A)LLZSubstantially EquivalentSiemens Healthcare GmbHaccessdata.fda.gov
December 20, 2023K230955syngo Application SoftwareLLZSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
December 15, 2023K230949ARTIS pheno (VE30A)OWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
December 14, 2023K230950ARTIS icono (VE30A)OWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
December 6, 2023K232206SOMATOM Pro.PulseJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
December 1, 2023K232856Syngo Carbon ClinicalsQIHSubstantially EquivalentSiemens Healthcare GmbHaccessdata.fda.gov
November 30, 2023K232155syngo.CT Dual EnergyJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
September 15, 2023K223812Sensis Vibe (VD15)DQKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 25, 2023K231577MOBILETT ImpactIZLSubstantially EquivalentSiemens Medical Solutionsaccessdata.fda.gov
July 19, 2023K231157syngo.CT Lung CAD (Version VD30)OEBSubstantially EquivalentSiemens Healthcare GmbHaccessdata.fda.gov
June 16, 2023K230421SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition FlashJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 21, 2023K230561Syngo Carbon Space VA30ALLZSubstantially EquivalentSiemens Healthcare GmbHaccessdata.fda.gov
February 13, 2023K230196syngo.via View&GO VA40ALLZSubstantially EquivalentSiemens Healthcare GmbHaccessdata.fda.gov
January 12, 2023K223363MAMMOVISTA B.smart (VB70)LLZSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
November 17, 2022K221281Multitom RaxOWBSubstantially EquivalentSiemens Medical Solutionsaccessdata.fda.gov
October 14, 2022K221501syngo.via View&GOLLZSubstantially EquivalentSiemens Healthcare GmbHaccessdata.fda.gov
September 7, 2022K220783syngo.via RT Image SuiteMUJSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
August 16, 2022K220433syngo Application Software (VE21)LLZSubstantially EquivalentSiemens Medical Solution USA, Inc.accessdata.fda.gov
July 19, 2022K221516ARTIS icono (Ceiling Configuration)OWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 13, 2022K221727syngo.CT Extended FunctionalityJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 12, 2022K220814NAEOTOM Alpha, Scan&GO SoftwareJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
June 29, 2022K220432ARTIS icono (VE21) SystemOWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
June 29, 2022K220409ARTIS pheno (VE21) SystemOWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
June 21, 2022K213665Syngo Carbon Space VA20ALLZSubstantially EquivalentSiemens Healthcare GmbHaccessdata.fda.gov
May 17, 2022K221219syngo.CT CaScoringJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 28, 2022K212889Syngo.CT Dual EnergyJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 16, 2022K212851EchoSK and EchoSGyn modules for EchoS Family devicesIYOSubstantially EquivalentEcholight S.P.Aaccessdata.fda.gov
March 7, 2022K220450syngo.CT ApplicationsJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
February 18, 2022K212212Multitom Rax with True2scale Body Scan OptionOWBSubstantially EquivalentSiemens Medical Solutionsaccessdata.fda.gov
January 28, 2022K203260syngo.CT Brain HemorrhageQASSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
January 20, 2022K214019syngo.CT Extended FunctionalityJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
December 6, 2021K213096Al-Rad Companion (Pulmonary)JAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
November 12, 2021K212621MAMMOVISTA B.smartLLZSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
September 30, 2021K211591NAEOTOM Alpha, Scan&GOJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
August 27, 2021K211373SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO SoftwareJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 30, 2021K211379syngo.via RT Image SuiteMUJSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 22, 2021K203411syngo.CT Skull UnfoldingJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 31, 2021K203258syngo.CT Lung CADOEBSubstantially EquivalentSiemens Healthcare GmbHaccessdata.fda.gov
February 25, 2021K202514EchoS FamilyMUASubstantially EquivalentEcholight S.P.Aaccessdata.fda.gov
February 5, 2021K210055Cios AlphaOWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
February 5, 2021K210054Cios SpinOWBSubstantially EquivalentSiemens Medical Systems USA, Inc.accessdata.fda.gov
December 22, 2020K203504Cios FlowOWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 21, 2020K201670YSIO X.preeKPRSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 11, 2020K202213syngo.CT Neuro PerfusionJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
August 13, 2020K201444Syngo.via RT Image SuiteMUJSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 1, 2020K201477syngo.via View&GOLLZSubstantially EquivalentSiemens Healthcare GmbHaccessdata.fda.gov
June 29, 2020K201156ARTIS pheno (VE2)OWBSubstantially EquivalentSiemens Medical Solution USA, Inc.accessdata.fda.gov
June 12, 2020K193166MAMMOMAT RevelationMUESubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
June 8, 2020K200015ePM Series Patient monitorsMHXSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
May 14, 2020K201034Syngo.CT CaScoringJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
April 16, 2020K193326ARTIS IconoOWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
April 1, 2020K200524SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GOJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 25, 2020K200515syngo.CT Cardiac PlanningJAKSubstantially EquivalentSiemens Medical Soultions USA, Inc.accessdata.fda.gov
March 16, 2020K193267Al-Rad Companion (Musculoskeletal)JAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 9, 2020K193216syngo.CT Lung CADOEBSubstantially EquivalentSiemens Medi Cal Solutions, Inc.accessdata.fda.gov
January 31, 2020K192462syngo.MR ApplicationsLLZSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
December 17, 2019K192763syngo.CT CaScoringJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
November 21, 2019K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GOJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
November 6, 2019K191891SOMATOM X.citeJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
September 20, 2019K192402syngo.CT Extended FunctionalityJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
September 18, 2019K192065Syngo.Via RT Image SuiteMUJSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
September 12, 2019K190780syngo Application SoftwareLLZSubstantially EquivalentSiemens Medical Solution USA, Inc.accessdata.fda.gov
September 12, 2019K190768ARTIS iconoOWBSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
September 10, 2019K183268AI-Rad Companion (Cardiovascular)JAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 26, 2019K183271AI-Rad Companion (Pulmonary)JAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 5, 2019K182904syngo.MR ApplicationsLLZSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 3, 2019K191468syngo.CT Dual EnergyJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
June 27, 2019K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM ConfidenceJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
April 21, 2015P140011MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTIONOTE8July 1, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
June 26, 202494892Class IIOngoingARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than inteaccessdata.fda.gov

Compare with other makers

Updated September 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. 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.