The following data is part of a De Novo classification by Philips Medical Systems Nederland B.v. with the FDA for Philips Intellisite Pathology Solution.
| DeNovo ID | DEN160056 |
| Device Name: | Philips IntelliSite Pathology Solution |
| Classification | Whole Slide Imaging System |
| Applicant | Philips Medical Systems Nederland B.V. veenpluis 4-6 Best, NL 5684 Pc |
| Contact | Esther Abels |
| Product Code | PSY |
| CFR Regulation Number | 864.3700 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Pathology |
| Classification Advisory | Pathology |
| Type | Direct |
| Date Received | 2016-12-01 |
| Decision Date | 2017-04-12 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |