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 And Ingenia 3.0t R5.3.
| Device ID | K163116 |
| 510k Number | K163116 |
| Device Name: | Ingenia 1.5T, Ingenia 1.5T S And Ingenia 3.0T R5.3 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best, NL 5684pc |
| Contact | Ruojuan Zhang |
| Correspondent | Ruojuan Zhang 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 | 2016-11-07 |
| Decision Date | 2017-01-06 |
| Summary: | summary |