The following data is part of a premarket notification filed by Philips Medical Systems Nederlands B.v. with the FDA for Intellispace Portal Platform.
| Device ID | K162025 |
| 510k Number | K162025 |
| Device Name: | IntelliSpace Portal Platform |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. VEENPLUIS 4-6 Room 542A Best, NL 5684 Pc |
| Contact | Ilana Ben Moshe |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-07-22 |
| Decision Date | 2016-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086449 | K162025 | 000 |
| 00884838075894 | K162025 | 000 |
| 00884838089808 | K162025 | 000 |
| 00884838093621 | K162025 | 000 |
| 00884838115613 | K162025 | 000 |
| 00884838121553 | K162025 | 000 |