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FDA PRODUCT CODE · CLASS II

QKQDigital 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.

DEVICE CLASS
Class II
REGULATION
21 CFR 864.3700
MEDICAL SPECIALTY
Pathology
REVIEW PANEL
PA
ImplantLife-sustainingGMP-exemptThird-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES

Recent clearances

K243449Infinitt Healthcare Co., Ltd. · 510k2025-12-09
K252762Indica Labs, LLC · 510k2025-11-25
K243391PathAI, Inc. · 510k2025-06-26
K250968Pathpresenter Corporation · 510k2025-06-20
K250414Tribun Health · 510k2025-05-14
K242244Lumea, Inc. · 510k2025-03-14
K241273Paige.Ai, Inc. · 510k2025-01-09
K240303Jellox Biotech, Inc. · 510k2024-10-28

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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