510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PZZClass II

Digital Pathology Display

21 CFR 864.3700 / Pathology
FDA source (opens on fda.gov)

PZZ is the FDA product code for Digital Pathology Display, a class II device type, regulated under 21 CFR 864.3700. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PZZ
Device name
Digital Pathology Display
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.
Regulation
21 CFR 864.3700
Device class
Class II
Review panel
Pathology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code PZZ

By decision year
3 clearances under product code PZZ with a decision year between 2017 and 2025, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PZZ by decision year
YearClearances
20171
20241
20251

Applicants with the most clearances

Product code PZZ
Applicants holding the most 510(k) clearances under product code PZZ
ApplicantClearances
Barco N.V.1
Eizo Corporation1
Shenzhen Beacon Display Technology Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code