Cleared Traditional

K212361 - Novo (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212361 · PathAI, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
377d
Days
Class 2
Risk

K212361 is an FDA 510(k) clearance for the Novo. Classified as Digital Pathology Image Viewing And Management Software (product code QKQ), Class II - Special Controls.

Submitted by PathAI, Inc. (Boston, US). The FDA issued a Cleared decision on August 11, 2022 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3700 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all PathAI, Inc. devices

Submission Details

510(k) Number K212361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
300d slower than avg
Panel avg: 77d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QKQ Digital Pathology Image Viewing And Management Software
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Peers - QKQ Digital Pathology Image Viewing And Management Software

All 12
Devices cleared under the same product code (QKQ) and FDA review panel - the closest regulatory comparables to K212361.
INFINITT DPS
K243449 · Infinitt Healthcare Co., Ltd. · Dec 2025
HALO AP Dx
K252762 · Indica Labs, LLC · Nov 2025
AISight Dx
K243391 · PathAI, Inc. · Jun 2025
PathPresenter Clinical Viewer
K250968 · Pathpresenter Corporation · Jun 2025
CaloPix
K250414 · Tribun Health · May 2025
Viewer+
K242244 · Lumea, Inc. · Mar 2025