Digital Pathology Image Viewing And Management Software
Pathology · 21 CFR 864.3700
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.
Recent MDR events
0 adverse event reports on file
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Event type breakdown
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Recalls
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Registered firms
13 firms currently registered for this product code
Sectra Ab
LINKOPING Ostergotland, SE
Pathpresenter Corp
Montville, NJ, US
Proscia, Inc.
Philadelphia, PA, US
Leica Biosystems Imaging, Inc.
Vista, CA, US
Paige.ai, Inc
New York, NY, US
Jellox Biotech Inc.
Hsinchu County, TW
Pathai
Boston, MA, US
Fujifilm Healthcare Americas Corporation
Lexington, MA, US
Infinitt Healthcare Co., Ltd.
SEOUL, KR
Tribun Health
PARIS Ile-de-France, FR
Shandon Diagnostics Limited
RUNCORN Cheshire East, GB
Indica Labs Llc
Albuquerque, NM, US
510(k) clearances
15 clearances for this product code
- Leica Biosystems Imaging, Inc.Aug 7, 2026
K253561 · Aperio iQC DX Software
- Proscia, Inc.Aug 5, 2026
K261380 · Concentriq AP-Dx
- Infinitt Healthcare Co., Ltd.Dec 9, 2025
K243449 · INFINITT DPS
- Indica Labs, LLCNov 25, 2025
K252762 · HALO AP Dx
- PathAI, Inc.Jun 26, 2025
K243391 · AISight Dx
- Pathpresenter CorporationJun 20, 2025
K250968 · PathPresenter Clinical Viewer
- Tribun HealthMay 14, 2025
K250414 · CaloPix
- Lumea, Inc.Mar 14, 2025
K242244 · Viewer+