Data / Medical devices / System, X-Ray, Mammographic
System, X-Ray, Mammographic (IZH): 14 FDA-registered makers in 5 countries
14 establishments in 5 countries are registered with the FDA to make System, X-Ray, Mammographic (product code IZH, Class 2, 21 CFR 892.1710). 11 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 176 510(k) clearances under this code, the latest on July 14, 2021, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IZH
- Device class
- 2
- Regulation
- 892.1710
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Japan | 2 |
| France | 1 |
| Italy | 1 |
| Thailand | 1 |
Makers of System, X-Ray, Mammographic
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hologic, Inc. | Newark, DE, United States | Complaint file establishment, Manufacturer | 11 | October 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems SCS | Buc, France | Manufacturer, Specification developer | 6 | April 19, 2004 | 0 | 0 | 0 | api.fda.gov |
| IMS GIOTTO S.p.A. | Sasso Marconi Bologna, Italy | Manufacturer | 5 | July 14, 2021 | 0 | 0 | 0 | api.fda.gov |
| Macbrud Corp., Medical Division | Crossings, FL, United States | Manufacturer | 2 | January 11, 2013 | 0 | 0 | 0 | api.fda.gov |
| BD Puerto Rico LLC | Juncos, PR, United States | Manufacturer | 1 | September 14, 1988 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 1 | September 14, 1988 | 0 | 0 | 0 | api.fda.gov |
| Beekley Corporation | Bristol, CT, United States | Manufacturer | 1 | March 26, 2008 | 0 | 1 | 0 | api.fda.gov |
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Manufacturer | 1 | July 3, 2019 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 1 | July 3, 2019 | 0 | 0 | 0 | api.fda.gov |
| Remington Medical, Inc. | Alpharetta, GA, United States | Manufacturer | 1 | November 3, 1998 | 0 | 0 | 0 | api.fda.gov |
| Remington Medical, Inc. | Alpharetta, GA, United States | Manufacturer | 1 | November 3, 1998 | 0 | 0 | 0 | api.fda.gov |
| Dion Label Printing, Inc. | Westfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foamtec International Co., Ltd. | Sriracha Chon Buri, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UFP Technologies, Inc. | Compton, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 14, 2021. 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.