Cleared Traditional

Novo

K212361 · PathAI, Inc. · Pathology
Aug 2022
Decision
377d
Days
Class 2
Risk

About This 510(k) Submission

K212361 is an FDA 510(k) clearance for the Novo, a Digital Pathology Image Viewing And Management Software (Class II — Special Controls, product code QKQ), submitted by PathAI, Inc. (Boston, US). The FDA issued a Cleared decision on August 11, 2022, 377 days after receiving the submission on July 30, 2021. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number K212361 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2021
Decision Date August 11, 2022
Days to Decision 377 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.