Cleared Traditional

FullFocus

K201005 · Paige.Ai, Inc. · Pathology
Jul 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K201005 is an FDA 510(k) clearance for the FullFocus, a Digital Pathology Image Viewing And Management Software (Class II — Special Controls, product code QKQ), submitted by Paige.Ai, Inc. (New York, US). The FDA issued a Cleared decision on July 15, 2020, 90 days after receiving the submission on April 16, 2020. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number K201005 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2020
Decision Date July 15, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code QKQ — Digital Pathology Image Viewing And Management Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.3700
Definition Digital Pathology Image Viewing And Management Software Device Is A Software Intended For Viewing And Management Of Digital Images Of Scanned Surgical Pathology Slides Prepared From Formalin-fixed Paraffin Embedded (ffpe) Tissue. It Is An Aid To The Pathologist To Review And Interpret These Digital Images For The Purposes Of Primary Diagnosis.