DEN160056 is an FDA 510(k) submission for the Philips IntelliSite Pathology Solution. This device is classified as a Whole Slide Imaging System (Class II - Special Controls, product code PSY).
Submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Not Cleared (DENG) decision on April 12, 2017.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3700. 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-embedded (ffpe) Tissue. The System Generates Digital Images That Would Otherwise Be Appropriate For Manual Visualization By Conventional Brightfield Microscopy. The Whole Slide Imaging System Is Not Intended For Use With Slides Prepared From Frozen Tissue, Cytology, And Non-ffpe Hematopathology Specimens (e.g., Peripheral Blood Smear)..
| 510(k) Number | DEN160056 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 01, 2016 |
| Decision Date | April 12, 2017 |
| Days to Decision | 132 days |
| Submission Type | Direct |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | PSY — Whole Slide Imaging System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.3700 |
| 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-embedded (ffpe) Tissue. The System Generates Digital Images That Would Otherwise Be Appropriate For Manual Visualization By Conventional Brightfield Microscopy. The Whole Slide Imaging System Is Not Intended For Use With Slides Prepared From Frozen Tissue, Cytology, And Non-ffpe Hematopathology Specimens (e.g., Peripheral Blood Smear). |