The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Ingenia Ambition S And Ingenia Ambition X.
| Device ID | K181479 |
| 510k Number | K181479 |
| Device Name: | Ingenia Ambition S And Ingenia Ambition X |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best, NL 5684pc |
| Contact | Jan Van De Kerkhof |
| Correspondent | Susan Quick Philips Medical Systems Nederland B.V. Miner Road 595 Cleveland, OH 44143 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-05 |
| Decision Date | 2018-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838090057 | K181479 | 000 |
| 00884838090040 | K181479 | 000 |