The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Achieva, Ingenia, Ingenia Cx, Ingenia Elition And Ingenia Ambition Mr Systems.
| Device ID | K213583 |
| 510k Number | K213583 |
| Device Name: | Achieva, 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. 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 | 2021-11-12 |
| Decision Date | 2022-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838108646 | K213583 | 000 |
| 00884838108639 | K213583 | 000 |
| 00884838108622 | K213583 | 000 |
| 00884838108615 | K213583 | 000 |
| 00884838108608 | K213583 | 000 |