PZZ — Digital Pathology Display Class II
FDA product code PZZ covers "Digital Pathology Display", a Class II medical device regulated under 21 CFR 864.3700. Submissions are reviewed by the Pathology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PZZ
- Device Class
- Class II
- Regulation Number
- 864.3700
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Definition
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.