510(k) K233119
K233119 is an FDA 510(k) premarket notification submitted by Shenzhen Beacon Display Technology Co., Ltd. for the device "8MP Color LCD Displays C811W, C811WT, PA27 and PA27T". The FDA issued a decision of Substantially Equivalent on December 28, 2024. The device falls under product code PZZ (Digital Pathology Display), a Class II device regulated under 21 CFR 864.3700. Shenzhen Beacon Display Technology Co., Ltd. has at least 10 other 510(k) clearances on record.
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.