510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QKQClass II

Digital Pathology Image Viewing And Management Software

21 CFR 864.3700 / Pathology
FDA source (opens on fda.gov)

QKQ is the FDA product code for Digital Pathology Image Viewing And Management Software, a class II device type, regulated under 21 CFR 864.3700. FDA's definition for this code reads: "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...". As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QKQ
Device name
Digital Pathology Image Viewing And Management Software
FDA 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.
Regulation
21 CFR 864.3700
Device class
Class II
Review panel
Pathology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
15
Ingested recalls
0

Clearances, product code QKQ

By decision year
15 clearances under product code QKQ with a decision year between 2020 and 2026, 2025 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code QKQ by decision year
YearClearances
20202
20222
20242
20257
20262

Applicants with the most clearances

Product code QKQ
Applicants holding the most 510(k) clearances under product code QKQ
ApplicantClearances
Paige.ai, Inc2
Pathai2
Aetherai Co., Ltd.1
Indica Labs LLC1
Infinitt Healthcare Co., Ltd.1
Inspirata, Inc.1
Jellox Biotech Inc.1
Leica Biosystems Imaging, Inc.1
Lumea, Inc.1
Pathpresenter Corp1

Companies listing this code with FDA

Companies whose registered establishments list this code