The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Philips Intellisite Pathology Solution.
| Device ID | K172174 |
| 510k Number | K172174 |
| 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 |
| Correspondent | Esther Abels Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best, NL 5684 Pc |
| Product Code | PSY |
| CFR Regulation Number | 864.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-19 |
| Decision Date | 2017-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838085640 | K172174 | 000 |