The following data is part of a premarket notification filed by Philips Electronics Nederland B.v. with the FDA for Philips Intellisite Pathology Solution.
| Device ID | K192259 |
| 510k Number | K192259 |
| Device Name: | Philips IntelliSite Pathology Solution |
| Classification | Whole Slide Imaging System |
| Applicant | Philips Electronics Nederland B.V. Veenpluis 6 Best, NL 5684 Pc |
| Contact | Liselotte Kornmann |
| Correspondent | Liselotte Kornmann Philips Electronics Nederland B.V. Veenpluis 6 Best, NL 5684 Pc |
| Product Code | PSY |
| CFR Regulation Number | 864.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-21 |
| Decision Date | 2019-09-20 |
| Summary: | summary |