510(k) K233119
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 2024
- Date Received
- September 27, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digital Pathology Display
- Device Class
- Class II
- Regulation Number
- 864.3700
- Review Panel
- PA
- Submission Type
The digital pathology display device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from FDA-cleared whole-slide imaging scanners that are used for review and interpretation by trained pathologists.