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Data / Medical devices / System, X-Ray, Tomography, Computed / United States

FDA-registered makers of System, X-Ray, Tomography, Computed in the United States: 45 establishments

45 establishments in the United States are registered with the FDA to make System, X-Ray, Tomography, Computed (product code JAK). 24 have a 510(k) clearance or PMA approval on file and 9 have a recall event. FDA data exported November 2, 2026.

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Device
System, X-Ray, Tomography, Computed
Product code
JAK
Country
United States

Makers of System, X-Ray, Tomography, Computed in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ge Medical Systems, LLCWaukesha, WI, United StatesManufacturer, Specification developer37June 24, 20260440api.fda.gov
Canon Medical Informatics, Inc.Minnetonka, MN, United StatesManufacturer, Repackager or relabeler8November 28, 2025000api.fda.gov
Covidien llcPlymouth, MN, United StatesComplaint file establishment, Manufacturer, Specification developer7August 7, 2019020api.fda.gov
Samsung HME America, Inc.Danvers, MA, United StatesComplaint file establishment, Manufacturer7September 8, 2025020api.fda.gov
Bunkerhill HealthSan Francisco, CA, United StatesManufacturer6March 6, 2026000api.fda.gov
Clear Guide MedicalBaltimore, MD, United StatesRepackager or relabeler, Specification developer5January 17, 2024000api.fda.gov
CurveBeam, LLCHatfield, PA, United StatesManufacturer5July 12, 2024000api.fda.gov
Philips Ultrasound LLCCambridge, MA, United StatesSpecification developer4January 18, 2023000api.fda.gov
Philips Ultrasound LLCBothell, WA, United StatesComplaint file establishment, Manufacturer4January 18, 2023000api.fda.gov
Acist Medical Systems, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Contract manufacturer2June 13, 2007000api.fda.gov
Bayer Medical Care Inc.Indianola, PA, United StatesComplaint file establishment, Specification developer2October 17, 2008020api.fda.gov
Neuwave Medical, Inc.Madison, WI, United StatesManufacturer2April 4, 2024000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer2December 17, 2021000api.fda.gov
Xoran Technologies, LLCAnn Arbor, MI, United StatesComplaint file establishment, Manufacturer, Remanufacturer2July 11, 2012090api.fda.gov
Bayer Medical Care Inc.Pittsburgh, PA, United StatesManufacturer1October 17, 2008000api.fda.gov
Carestream Health, IncRochester, NY, United StatesManufacturer1August 30, 2016010api.fda.gov
Edda Technology, Inc.Princeton, NJ, United StatesComplaint file establishment, Manufacturer1November 20, 2015000api.fda.gov
Icad Inc.Nashua, NH, United StatesManufacturer1August 4, 2010000api.fda.gov
Imaging Biometrics, LLCElm Grove, WI, United StatesComplaint file establishment, Manufacturer1October 29, 2020000api.fda.gov
Leo Cancer Care IncorporatedMiddleton, WI, United StatesManufacturer1July 25, 2025000api.fda.gov
Mobius Imaging, LLCShirley, MA, United StatesSpecification developer1March 15, 2018070api.fda.gov
PULMONX, Corp.Redwood City, CA, United StatesComplaint file establishment, Manufacturer1September 2, 2021000api.fda.gov
Riverain TechnologiesMiamisburg, OH, United StatesManufacturer1December 3, 2024000api.fda.gov
Vida DiagnosticsCoralville, IA, United StatesManufacturer1August 7, 2020000api.fda.gov
Alken, Inc. D/B/A PolhemusColchester, VT, United StatesContract manufacturer0000api.fda.gov
Anholt Technologies Inc.Avondale, PA, United StatesManufacturer0000api.fda.gov
Auris Health, IncSanta Clara, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Auris Health, Inc.San Jose, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GEXPRO, a Division of REXEL USA, Inc.Menomonee Falls, WI, United StatesContract manufacturer0000api.fda.gov
Heartlung CorporationHouston, TX, United StatesManufacturer0000api.fda.gov
HM Product Solutions, Ltd.Hartland, WI, United StatesContract manufacturer0000api.fda.gov
Intricon CorporationArden Hills, MN, United StatesContract manufacturer0000api.fda.gov
Invia, LLCAnn Arbor, MI, United StatesManufacturer0000api.fda.gov
Izi Medical Products LLCOwings Mills, MD, United StatesManufacturer0000api.fda.gov
Kapstone ManufacturingCharlotte, NC, United StatesContract manufacturer0000api.fda.gov
Multifunctional Imaging LLCMorgan, UT, United StatesManufacturer0000api.fda.gov
Nview MedicalSalt Lake City, UT, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Pulmera Inc.Charlotte, NC, United StatesSpecification developer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Siemens Medical Solutions Usa, Inc.Knoxville, TN, United StatesSpecification developer0000api.fda.gov
Siemens Medical Solutions Usa, Inc.Hoffman Estates, IL, United StatesManufacturer, Remanufacturer0060api.fda.gov
Stryker Corp.Kalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Syntermed, Inc.Atlanta, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Uih Technologies, LLCHouston, TX, United StatesContract manufacturer0010api.fda.gov
Vonco Products, LLCFortville, IN, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 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.