FullFocus— 510(k) K241273

Substantially Equivalent

Paige.Ai, Inc.

FDA 510(k) clearance K241273 for FullFocus, Substantially Equivalent on 2025-01-09. Applicant: Paige.Ai, Inc.. Device class: 2.

Clearance details

Applicant: Paige.Ai, Inc.
Product code: Code QKQ
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2024-05-06
Decision date: 2025-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Paige.Ai, Inc.

K201005 — FullFocus2020-07-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.