Definition: The Whole Slide Imaging System Is An Automated Digital Slide Creation, Viewing, And Management System Intended As An Aid To The Pathologist To Review And Interpret Digital Images Of Surgical Pathology Slides Prepared From Formalin-fixed, Paraffin-emb
| Device Type ID | 5029 |
| Device Name | Whole Slide Imaging System |
| Physical State | The Whole Slide Imaging System Consists Of An Image Management System, A Scanner And Associated Software, And A Display Monitor. The Whole Slide Imaging System Does Not Include Any Automated Image Analysis Applications That Would Constitute Computer |
| Technical Method | The Whole Slide Imaging System Consists Of An Image Management System, A Scanner And Associated Software, And A Display Monitor. Pathologists View And Interpret Scanned Digital Images, Employing Appropriate Processes To Ensure The Validity Of The Int |
| Target Area | Surgical Pathology Slides Prepared From Formalin-fixed, Paraffin-embedded (FFPE) Tissue Not For Use With Slides Prepared From Frozen Tissue, Cytology, And Non-FFPE Hematopathology 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 | PSY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5029 |
| Device | Whole Slide Imaging System |
| Product Code | PSY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Whole Slide Imaging System. |
| CFR Regulation Number | 864.3700 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BARCO NV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |