The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Ingenia 1.5t, Ingenia 1 5t S, Ingenia 1.5t Cx, Ingenia 3.0t Cx R5.4.
| Device ID | K173079 |
| 510k Number | K173079 |
| Device Name: | Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX 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 Kerkhot |
| Correspondent | Susan Quick Philips Medical Systems (Cleveland) Inc 595 Miner Road 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 | 2017-09-29 |
| Decision Date | 2018-04-04 |
| Summary: | summary |