Pathology
INFINITT DPS
Infinitt Healthcare Co., Ltd.
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.
FDA Submission Metadata
- Submission number
- K243449
- Decision date
- December 2025
- FDA panel
- Pathology
- Product code
- QKQ
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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