Data / Medical devices / Analyzer, Medical Image / United States
FDA-registered makers of Analyzer, Medical Image in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Analyzer, Medical Image (product code MYN). 12 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Analyzer, Medical Image
- Product code
- MYN
- Country
- United States
Makers of Analyzer, Medical Image in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Pearl Inc. | West Hollywood, CA, United States | Complaint file establishment, Manufacturer | 6 | November 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Imagen Technologies, Inc. | New York, NY, United States | Complaint file establishment, Manufacturer | 4 | October 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Overjet | Boston, MA, United States | Manufacturer | 4 | March 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Icad Inc. | Nashua, NH, United States | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Bench7, Inc | Bismarck, ND, United States | Manufacturer | 1 | November 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Better Diagnostics Ai Corp | Avon, CT, United States | Manufacturer | 1 | March 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| DGNCT LLC | Miami, FL, United States | Manufacturer | 1 | January 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | Newark, DE, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Qview Medical, Inc. | Los Altos, CA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Riverain Technologies | Miamisburg, OH, United States | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Velmeni | Sunnyvale, CA, United States | Manufacturer | 1 | August 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| VideaHealth, Inc. | Boston, MA, United States | Manufacturer | 1 | December 15, 2023 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.