The following data is part of a premarket notification filed by Philips Medical Systems Nederland, B.v. with the FDA for Ingenia 3.0t, Ingenia 3.0t Cx, Ingenia Elition And Mr 7700 With Distributed Multi Nudclei.
| Device ID | K213516 |
| 510k Number | K213516 |
| Device Name: | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition And MR 7700 With Distributed Multi Nudclei |
| 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 | Jan Van De Kerkhof 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 | 2021-11-03 |
| Decision Date | 2022-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838104129 | K213516 | 000 |
| 00884838104112 | K213516 | 000 |