The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Ingenia Elition S And Ingenia Elition X R5.4.
| Device ID | K173356 |
| 510k Number | K173356 |
| Device Name: | Ingenia Elition S And Ingenia Elition X R5.4 |
| 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 | Henrie Daniels Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best, NL 5684pc |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-25 |
| Decision Date | 2018-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838088115 | K173356 | 000 |
| 00884838088108 | K173356 | 000 |