Data / Medical devices / United States / Paige.ai, Inc
Paige.ai, Inc: FDA-registered device maker in New York, NY, United States, 3 510(k) clearances
Paige.ai, Inc is registered with the FDA (registration 3017125738) in New York, NY, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017125738
- Address
- 33 Irving Place 3rd Floor, New York, NY, United States, 10003
- Owner or operator
- Paige.AI, Inc (10076458)
- Roles
- Manufacturer
- First device listed
- July 20, 2020
- Registered through
- 2026
- Brand names listed
- FullFocus, Paige Prostate Detect
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Digital Pathology Image Viewing And Management Software | QKQ | 2 | Manufacturer | accessdata.fda.gov |
| Software Algorithm Device To Assist Users In Digital Pathology | QPN | 2 | Manufacturer | accessdata.fda.gov |
| Whole Slide Imaging System | PSY | 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 |
|---|---|---|---|---|---|---|
| January 9, 2025 | K241273 | FullFocus | QKQ | Substantially Equivalent | Paige.Ai, Inc. | accessdata.fda.gov |
| September 21, 2021 | DEN200080 | Paige Prostate | QPN | Unknown | Paige.Ai | accessdata.fda.gov |
| July 15, 2020 | K201005 | FullFocus | QKQ | Substantially Equivalent | Paige.Ai, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Whole Slide Imaging System
- All makers of Digital Pathology Image Viewing And Management Software
Updated January 9, 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.