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Data / Medical devices / Automated Radiological Image Processing Software / United States

FDA-registered makers of Automated Radiological Image Processing Software in the United States: 69 establishments

69 establishments in the United States are registered with the FDA to make Automated Radiological Image Processing Software (product code QIH). 49 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Automated Radiological Image Processing Software
Product code
QIH
Country
United States

Makers of Automated Radiological Image Processing Software in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Medical Solutions Usa, Inc.Hoffman Estates, IL, United StatesManufacturer7February 10, 2026000api.fda.gov
Ischemaview, Inc.Golden, CO, United StatesManufacturer5September 23, 2025000api.fda.gov
Philips Ultrasound LLCBothell, WA, United StatesComplaint file establishment, Manufacturer, Specification developer5March 6, 2025000api.fda.gov
DeephealthSomerville, MA, United StatesManufacturer4May 21, 2026000api.fda.gov
Exo Imaging, Inc.Santa Clara, CA, United StatesManufacturer4November 20, 2024000api.fda.gov
OverjetBoston, MA, United StatesManufacturer4April 10, 2026000api.fda.gov
Ceevra, Inc.San Francisco, CA, United StatesManufacturer3March 4, 2025000api.fda.gov
Curemetrix, Inc.San Diego, CA, United StatesManufacturer3July 30, 2026000api.fda.gov
Siemens Medical Solutions Usa, Inc.Ann Arbor, MI, United StatesManufacturer3April 10, 2026000api.fda.gov
Subtle Medical IncMenlo Park, CA, United StatesManufacturer3May 15, 2026000api.fda.gov
Terarecon, Inc.Fremont, CA, United StatesComplaint file establishment, Manufacturer3October 23, 2025000api.fda.gov
Viz.ai, Inc.Cary, NC, United StatesComplaint file establishment, Specification developer3June 10, 2025000api.fda.gov
Cleerly, IncDenver, CO, United StatesManufacturer2July 29, 2026000api.fda.gov
Cortechs Labs, Inc.Cov, KY, United StatesManufacturer2August 22, 2024000api.fda.gov
Ezra Ai, Inc.New York, NY, United StatesManufacturer2January 2, 2025000api.fda.gov
FUJIFILM Healthcare Americas CorporationDurham, NC, United StatesManufacturer2June 18, 2026000api.fda.gov
Ge Medical Systems, LLCWaukesha, WI, United StatesManufacturer, Specification developer2April 14, 2026000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesSpecification developer2December 16, 2025000api.fda.gov
Neosoma, Inc.Groton, MA, United StatesManufacturer2December 17, 2025000api.fda.gov
Pearl Inc.West Hollywood, CA, United StatesComplaint file establishment, Manufacturer2May 23, 2025000api.fda.gov
Philips Ultrasound LLCCambridge, MA, United StatesManufacturer, Specification developer2June 3, 2020000api.fda.gov
Simbiosys, Inc.Chicago, IL, United StatesManufacturer2July 8, 2025000api.fda.gov
Angiowave Imaging, Inc.Concord, MA, United StatesManufacturer1September 10, 2025000api.fda.gov
Argus Cognitive, Inc.Hanover, NH, United StatesManufacturer1September 9, 2026000api.fda.gov
Arterys Inc.Chicago, IL, United StatesManufacturer1September 3, 2025000api.fda.gov
Bunkerhill HealthSan Francisco, CA, United StatesManufacturer1July 1, 2025000api.fda.gov
Canon Medical Informatics, Inc.Minnetonka, MN, United StatesManufacturer1May 22, 2026000api.fda.gov
Carlsmed, Inc.Carlsbad, CA, United StatesManufacturer1November 3, 2023000api.fda.gov
Cycle ClarityAwendaw, SC, United StatesComplaint file establishment, Manufacturer1January 19, 2022000api.fda.gov
ClearPoint Neuro Inc.Carlsbad, CA, United StatesManufacturer1August 8, 2022000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer1March 6, 2026000api.fda.gov
DGNCT LLCMiami, FL, United StatesManufacturer1September 9, 2025000api.fda.gov
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLCWaukesha, WI, United StatesManufacturer, Specification developer1January 19, 2022000api.fda.gov
Genesis Software InnovationsGrand Rapids, MI, United StatesManufacturer1April 21, 2021000api.fda.gov
Heartlung CorporationHouston, TX, United StatesManufacturer1October 10, 2024000api.fda.gov
Hyperfine, IncGuilford, CT, United StatesManufacturer, Specification developer1December 16, 2022000api.fda.gov
Icad Inc.Nashua, NH, United StatesManufacturer1July 12, 2021000api.fda.gov
Invision Medical TechnologySunnyvale, CA, United StatesManufacturer1April 25, 2024000api.fda.gov
Medical Metrics, Inc.Houston, TX, United StatesManufacturer1July 7, 2023000api.fda.gov
Orthogrid Systems, IncMidvale, UT, United StatesComplaint file establishment, Manufacturer1May 29, 2026000api.fda.gov
Q BioSan Carlos, CA, United StatesComplaint file establishment, Manufacturer1September 12, 2024000api.fda.gov
Roche Molecular Systems, Inc.Pleasanton, CA, United StatesSpecification developer1May 30, 2025000api.fda.gov
Remedy Logic, IncNew York, NY, United StatesManufacturer, Specification developer1October 30, 2024000api.fda.gov
Roche Diagnostics Santa ClaraSanta Clara, CA, United StatesManufacturer1May 30, 2025000api.fda.gov
Sora NeuroscienceMinneapolis, MN, United StatesComplaint file establishment, Manufacturer1June 6, 2025000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Manufacturer1September 29, 2023000api.fda.gov
Vent CreativityNew York, NY, United StatesManufacturer1March 20, 2025000api.fda.gov
VideaHealth, Inc.Boston, MA, United StatesManufacturer1February 6, 2023000api.fda.gov
Whiterabbit Ai IncRedwood City, CA, United StatesSpecification developer1October 30, 2020000api.fda.gov
Butterfly Network, Inc.Burlington, MA, United StatesManufacturer, Specification developer0000api.fda.gov
BioticsAI, Inc.San Francisco, CA, United StatesManufacturer0000api.fda.gov
Echonous, Inc.Redmond, WA, United StatesManufacturer0000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesContract manufacturer0000api.fda.gov
Fujifilm Sonosite,inc.Bothell, WA, United StatesManufacturer0000api.fda.gov
GE Medical Systems Ultrasound & Primary Care Diagnostics LLCNoblesville, IN, United StatesManufacturer, Remanufacturer0000api.fda.gov
Ge Parallel Design, Inc.Phoenix, AZ, United StatesManufacturer0000api.fda.gov
GEXPRO, a Division of REXEL USA, Inc.Menomonee Falls, WI, United StatesContract manufacturer0000api.fda.gov
Heartflow, Inc.San Francisco, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Insight Medical Systems, IncAustin, TX, United StatesSpecification developer0000api.fda.gov
Koios Medical, Inc.New York, NY, United StatesManufacturer0000api.fda.gov
Myrava, LLCParma, OH, United StatesContract manufacturer0000api.fda.gov
PRENUVO Inc.Redwood City, CA, United StatesManufacturer0000api.fda.gov
Philips Ultrasound LLCReedsville, PA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Radformation, Inc.New York, NY, United StatesManufacturer0000api.fda.gov
Siemens Medical Solutions Usa, Inc.Issaquah, WA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Sound Technology Inc.State College, PA, United StatesManufacturer0000api.fda.gov
Uih Technologies, LLCHouston, TX, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Verdure Imaging IncStockton, CA, United StatesManufacturer0000api.fda.gov
X9 Inc.Wallingford, CT, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.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.