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Data / Medical devices / System, X-Ray, Tomographic

System, X-Ray, Tomographic (IZF): 15 FDA-registered makers in 9 countries

15 establishments in 9 countries are registered with the FDA to make System, X-Ray, Tomographic (product code IZF, Class 2, 21 CFR 892.1740). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 42 510(k) clearances under this code, the latest on February 2, 2026, and lists 4 recall events (0 Class I). 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 every maker of this deviceMakers in the United StatesWatch this device
Product code
IZF
Device class
2
Regulation
892.1740
Medical specialty
Radiology

Makers by country

CountryMakers
United States3
Israel2
United Kingdom2
Japan2
China2
Belgium1
Germany1
Italy1
Mexico1

Makers of System, X-Ray, Tomographic

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Nano-X Imaging LtdPETAH TIKVA Central, IsraelManufacturer4February 2, 2026000api.fda.gov
Agfa N.V.Mortsel Antwerpen, BelgiumComplaint file establishment, Manufacturer, Specification developer2March 9, 2020010api.fda.gov
Accogent PauschEatontown, NJ, United StatesManufacturer2June 17, 1998000api.fda.gov
Adaptix LimitedOxford Oxfordshire, United KingdomComplaint file establishment, Exporter to the US, Specification developer1November 6, 2025000api.fda.gov
Agfa-Gevaert Healthcare GMBHPEISSENBERG Bavaria, GermanyManufacturer1March 9, 2020000api.fda.gov
Fujifilm CorporationASHIGARAKAMI-GUN Kanagawa, JapanComplaint file establishment, Manufacturer1November 20, 2012000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Hanamaki OfficeHANAMAKI-SHI Iwate, JapanManufacturer1November 20, 2012000api.fda.gov
Ge Hangwei Medical Systems Co., Ltd.Beijing, ChinaManufacturer1November 18, 2013000api.fda.gov
GE Healthcare (China) Co., Ltd.Beijing, ChinaSpecification developer1November 18, 2013000api.fda.gov
General Medical Merate S.P.A.Seriate, Bergamo, ItalyManufacturer1October 26, 2021000api.fda.gov
Dagesh F.K. Ltd.Yad Binyamin Central, IsraelContract manufacturer0000api.fda.gov
Ge Medical Systems Monterrey Mexico, S.A. De C.V.APODACA Nuevo Leon, MexicoManufacturer0000api.fda.gov
Ge Medical Systems, LLCWaukesha, WI, United StatesManufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Zot Engineering LimitedMusselburgh East Lothian, United KingdomContract manufacturer0000api.fda.gov

Updated February 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.