Data / Medical devices / Full Field Digital, System, X-Ray, Mammographic / United States
FDA-registered makers of Full Field Digital, System, X-Ray, Mammographic in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Full Field Digital, System, X-Ray, Mammographic (product code MUE). 4 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
- Full Field Digital, System, X-Ray, Mammographic
- Product code
- MUE
- Country
- United States
Makers of Full Field Digital, System, X-Ray, Mammographic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Metropolis International, LLC | Long Island City, NY, United States | Remanufacturer, Repackager or relabeler | 3 | June 11, 2013 | 1 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | Newark, DE, United States | Complaint file establishment, Manufacturer | 1 | January 29, 2013 | 1 | 0 | 0 | api.fda.gov |
| Carestream Health, Inc | Rochester, NY, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| iCRco Inc. | Goleta, CA, United States | Manufacturer | 1 | April 26, 2013 | 0 | 0 | 0 | api.fda.gov |
| HM Product Solutions, Ltd. | Hartland, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Medical Solutions Usa, Inc. | Hoffman Estates, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.