Atlas FDA

PZZ

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Digital Pathology Display
Device class
Class II (moderate risk)
Regulation
21 CFR 864.3700
Medical specialty
Pathology
Flags
Third-party review eligible
FDA 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.
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RecordFirmDate
RadiForce MX317W-PA (K242545)Eizo Corporation2025-05-23
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T (K233119)Shenzhen Beacon Display Technology Co., Ltd.2024-12-28
MMPC-4127F1 (K172922)Barco N.V.2017-12-21

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Every clearance here is in the API, with alerts when new ones post.