FullFocus— 510(k) K201005

Substantially Equivalent

Paige.Ai, Inc.

FDA 510(k) clearance K201005 for FullFocus, Substantially Equivalent on 2020-07-15. 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: 2020-04-16
Decision date: 2020-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QKQ

K261380 — Concentriq AP-Dx2026-08-05
K243449 — INFINITT DPS2025-12-09
K252762 — HALO AP Dx2025-11-25
K243391 — AISight Dx2025-06-26
K250968 — PathPresenter Clinical Viewer2025-06-20

More clearances from Paige.Ai, Inc.

K241273 — FullFocus2025-01-09

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