1 device · 1 company · 2025
Product code QKQ: Digital Pathology Image Viewing And Management Software
1 device under product code QKQ, 2025, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Digital Pathology Image Viewing And Management Software. 21 CFR 864.3700, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
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| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| INFINITT DPSK243449 · 510(k) | Infinitt Healthcare Co., Ltd. | Pathology | database entry |
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