Data / Medical devices / United States / Clairity, Inc.
Clairity, Inc.: FDA-registered device maker in Boston, MA, United States, 1 510(k) clearance
Clairity, Inc. is registered with the FDA (registration 3042248140) in Boston, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042248140
- Address
- 361 Newbury St Ste 402, Boston, MA, United States, 02115
- Owner or operator
- Clairity, Inc. (10094517)
- Roles
- Manufacturer
- First device listed
- December 4, 2025
- Registered through
- 2026
- Brand names listed
- Clairity Breast
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Software Device To Predict Future Breast Cancer Risk | SEZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2025 | DEN240047 | Allix5 | SEZ | Unknown | Clairity, Inc. | accessdata.fda.gov |
Updated May 30, 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.