PAIGE.AI, INC

FDA Device Registration & Listing · New York, NY, US · Registration 3017125738

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017125738
FEI Number
3017125738
Entity Name
PAIGE.AI, INC
City/State/Country
New York, NY, US
Establishment Address
33 Irving Place, 3rd Floor, New York, NY 10003, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Paige.AI, Inc (Owner Number: 10076458)
Owner / Operator Contact Address
33 Irving Place, 3rd Floor, New York, NY 10003, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN200080
PMA Number
N/A

All Registered Proprietary Names

FullFocus FullFocus Paige Prostate Detect

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PSY Whole Slide Imaging System Pathology Class 2 864.3700 2025-12-18
QKQ Digital Pathology Image Viewing And Management Software Pathology Class 2 864.3700 2025-12-18
QKQ Digital Pathology Image Viewing And Management Software Pathology Class 2 864.3700 2020-07-20
PSY Whole Slide Imaging System Pathology Class 2 864.3700 2020-07-20
QPN Software Algorithm Device To Assist Users In Digital Pathology Pathology Class 2 864.3750 2021-09-25

Official Correspondent

Bensu Altan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Paige.AI, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243871 Philips Medical Systems Nederland B.V. Philips IntelliSite Pathology Solution 5.1 2025-03-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017125738. Last updated year: 2026. Please use registration number 3017125738 when referencing this establishment in official correspondence.
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