Digital Pathology Display
Device Code: 5031
Product Code(s):
PZZ 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
Device Classification Information
| Device Type ID | 5031 |
| Device Name | Digital Pathology Display |
| Physical State | Hardware And Embedded Software |
| Technical Method | Hardware And Embedded Software For Displaying Digital Pathology Images Of Tissue On Glass Slides. |
| Target Area | Histopathology Slides Of Human Clinical Tissue Specimens |
| Regulation Description | Whole Slide Imaging System. |
| Regulation Medical Specialty | Pathology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 864.3700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5031 |
| Device | Digital Pathology Display |
| Product Code | PZZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Whole Slide Imaging System. |
| CFR Regulation Number | 864.3700 [🔎] |
TPLC Last Update: 2019-04-02 20:59:06