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

System, Therapeutic, X-Ray (JAD): 15 FDA-registered makers in 6 countries

15 establishments in 6 countries are registered with the FDA to make System, Therapeutic, X-Ray (product code JAD, Class 2, 21 CFR 892.5900). 9 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 53 510(k) clearances under this code, the latest on December 3, 2025, and lists 9 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
JAD
Device class
2
Regulation
892.5900
Medical specialty
Radiology

Makers by country

CountryMakers
United States10
Sweden1
Germany1
United Kingdom1
Netherlands1
Mexico1

Makers of System, Therapeutic, X-Ray

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
Elekta Solutions ABStockholm, SwedenSpecification developer9February 25, 2016000api.fda.gov
Carl Zeiss Meditec AG (oberkochen)OBERKOCHEN Baden-Wurttemberg, GermanyManufacturer7January 10, 2025020api.fda.gov
Sensus HealthcareBoca Raton, FL, United StatesComplaint file establishment, Specification developer3March 23, 2018010api.fda.gov
Xstrahl LimitedWALSALL, WEST MIDLANDS Staffordshire, United KingdomComplaint file establishment, Manufacturer3July 13, 2023030api.fda.gov
Empyrean Medical Systems, Inc.Boca Raton, FL, United StatesSpecification developer2February 21, 2019000api.fda.gov
Nucletron B.V.VEENENDAAL Utrecht, NetherlandsManufacturer2January 11, 2022000api.fda.gov
Action Products, Inc.Hagerstown, MD, United StatesManufacturer1July 10, 1981010api.fda.gov
Huestis Machine Corp.Bristol, RI, United StatesManufacturer1November 29, 1990000api.fda.gov
Voxel Ray Solutions, LLCBurr Ridge, IL, United StatesSpecification developer1December 3, 2025000api.fda.gov
Elekta Inc.San Jose, CA, United StatesContract manufacturer0000api.fda.gov
Fabtech Precision Sheet Metal, LLCSpokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Koplak CorpSunrise, FL, United StatesContract manufacturer0000api.fda.gov
Parker Industrial S de RL de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
RBM Services, LLC.Knoxville, TN, United StatesContract manufacturer0000api.fda.gov
Stellartech Research Corp.Milpitas, CA, United StatesContract manufacturer0000api.fda.gov

Updated December 3, 2025. 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.