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Data / Medical devices / System, Tomography, Computed, Emission / United States

FDA-registered makers of System, Tomography, Computed, Emission in the United States: 22 establishments

22 establishments in the United States are registered with the FDA to make System, Tomography, Computed, Emission (product code KPS). 14 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
System, Tomography, Computed, Emission
Product code
KPS
Country
United States

Makers of System, Tomography, Computed, Emission in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Medical Solutions Usa, Inc.Hoffman Estates, IL, United StatesManufacturer, Remanufacturer26May 21, 20260350api.fda.gov
Siemens Medical Solutions Usa, Inc.Knoxville, TN, United StatesSpecification developer17July 31, 20250140api.fda.gov
Ge Medical Systems, LLCWaukesha, WI, United StatesManufacturer, Specification developer11August 8, 20240332api.fda.gov
Ultraspect Usa, LLCGray, TN, United StatesManufacturer8January 19, 2011000api.fda.gov
Cardiovascular Imaging Technologies, LLCKansas City, MO, United StatesManufacturer4August 11, 2020000api.fda.gov
Syntermed, Inc.Atlanta, GA, United StatesManufacturer, Repackager or relabeler, Specification developer4March 30, 2023000api.fda.gov
Subtle Medical IncMenlo Park, CA, United StatesManufacturer2September 28, 2021000api.fda.gov
Cedars Sinai Medical CenterLos Angeles, CA, United StatesManufacturer1November 3, 2017000api.fda.gov
Digirad Diagnostic Imaging, LLCPoway, CA, United StatesManufacturer1October 4, 2005000api.fda.gov
E-Z-Em, Inc.Princeton, NJ, United StatesSpecification developer1June 12, 2018000api.fda.gov
Medimage, Inc.Ann Arbor, MI, United StatesManufacturer1November 3, 1993000api.fda.gov
Microstructure Imaging, IncBrooklyn, NY, United StatesSpecification developer1September 11, 2026000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer1June 3, 2011000api.fda.gov
Sirtex Medical Inc.Woburn, MA, United StatesComplaint file establishment, Specification developer1October 23, 2020000api.fda.gov
Anholt Technologies Inc.Avondale, PA, United StatesManufacturer0000api.fda.gov
GEXPRO, a Division of REXEL USA, Inc.Menomonee Falls, WI, United StatesContract manufacturer0000api.fda.gov
HM Product Solutions, Ltd.Hartland, WI, United StatesContract manufacturer0000api.fda.gov
Invia, LLCAnn Arbor, MI, United StatesManufacturer0000api.fda.gov
Multifunctional Imaging LLCMorgan, UT, United StatesManufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
RBM Services, LLC.Knoxville, TN, United StatesContract manufacturer0000api.fda.gov
Uih Technologies, LLCHouston, TX, 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.