FDA Product Code QKQ: Digital Pathology Image Viewing And Management Software
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.
Leading manufacturers include Paige.Ai, Inc., PathAI, Inc. and Indica Labs, LLC.
13
Total
13
Cleared
219d
Avg days
2020
Since
Growing category -
8 submissions in the last 2 years
vs 2 in the prior period
Review times improving: avg
205d
recently vs 243d historically
FDA 510(k) Cleared Digital Pathology Image Viewing And Management Software Devices (Product Code QKQ)
13 devices
Cleared
Dec 09, 2025
INFINITT DPS
Infinitt Healthcare Co., Ltd.
Pathology
397d
Cleared
Nov 25, 2025
HALO AP Dx
Indica Labs, LLC
Pathology
88d
Cleared
Jun 26, 2025
AISight Dx
PathAI, Inc.
Pathology
238d
Cleared
Jun 20, 2025
PathPresenter Clinical Viewer
Pathpresenter Corporation
Pathology
81d
Cleared
May 14, 2025
CaloPix
Tribun Health
Pathology
90d
Cleared
Mar 14, 2025
Viewer+
Lumea, Inc.
Pathology
226d
Cleared
Jan 09, 2025
FullFocus
Paige.Ai, Inc.
Pathology
248d
Cleared
Oct 28, 2024
MetaLite DX Digital Pathology Software
Jellox Biotech, Inc.
Pathology
269d
Cleared
May 30, 2024
aetherSlide
Aetherai Co., Ltd.
Pathology
246d
Cleared
Aug 11, 2022
Novo
PathAI, Inc.
Pathology
377d
Cleared
Mar 01, 2022
Dynamyx Digital Pathology Software
Inspirata, Inc.
Pathology
349d
Cleared
Jul 15, 2020
FullFocus
Paige.Ai, Inc.
Pathology
90d
Cleared
Mar 31, 2020
Sectra Digital Pathology Module
Sectra AB
Pathology
151d
About Product Code QKQ - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code QKQ since 2020, with 13 receiving FDA clearance (average review time: 219 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QKQ Product Code
Recent submissions under QKQ have taken an average of 205 days to reach a decision - down from 243 days historically, suggesting improved FDA processing for this classification.
QKQ devices are reviewed by the Pathology panel. Browse all Pathology devices →