FullFocus
Paige.Ai, Inc.
PAIGE.AI, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017125738 | 3017125738 | PAIGE.AI, INC | 1 | N | 2026-01-01 | 33 Irving Place 3rd Floor New York NY US 10003 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 274691 | 2054728780 | K241273 | FullFocus | QKQ | 2025-01-09 |
| 274691 | 1895102245 | K201005 | FullFocus | QKQ | 2020-07-15 |
| 274691 | 1146359526 | DEN200080 | Paige Prostate | QPN | 2021-09-21 |
Product Codes Associated With Registrations#
PMN#
FullFocus
Paige.AI, Inc
GUDID#
Paige Prostate - Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.
2021-11-10
FullFocusTM Whole Slide Image Viewer - FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus renders the uploaded slide images and is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis.
2021-09-23