The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Ingenia, Ingenia Cx, Ingenia Elition, And Ingenia Ambition Mr Systems.
| Device ID | K183063 |
| 510k Number | K183063 |
| Device Name: | Ingenia, Ingenia CX, Ingenia Elition, And Ingenia Ambition MR Systems |
| 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. 595 Miner Rd 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 | 2018-11-05 |
| Decision Date | 2019-02-14 |
| Summary: | summary |