Digital Pathology Display
The Digital Pathology Display is an in vitro diagnostic device intended to display digital images of histopathology slides acquired from FDA-cleared whole-slide imaging scanners for review and interpretation by trained pathologists. It is classified as a Class 2 device under regulation 864.3700, requiring 510(k) premarket notification and eligible for third-party review, and falls within the Pathology (PA) medical specialty. The product code is PZZ. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- PZZ
- Device Class
- FDA class 2
- Regulation Number
- 864.3700
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242545 | RadiForce MX317W-PA | May 23, 2025 | Substantially Equivalent | Eizo Corporation |
| K233119 | 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T | Dec 28, 2024 | Substantially Equivalent | Shenzhen Beacon Display Technology Co., Ltd. |
| K172922 | MMPC-4127F1 | Dec 21, 2017 | Substantially Equivalent | Barco N.V. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.