The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for Achieva, Intera, Ingenia, Ingneia Cx, Ingenia Elition, And Ingenia Ambition Mr Systems.
| Device ID | K193215 |
| 510k Number | K193215 |
| Device Name: | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, And Ingenia Ambition MR Systems |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Philips Medical Systems Nederland BV Veenpluis 4-6 Best, NL 5684pc |
| Contact | Jan Van De Kerkhof |
| Correspondent | Susan Quick Philips Medical Systems Nederland B.V. 595 Miner Rd 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 | 2019-11-21 |
| Decision Date | 2020-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838099715 | K193215 | 000 |
| 00884838099456 | K193215 | 000 |
| 00884838099463 | K193215 | 000 |
| 00884838099470 | K193215 | 000 |
| 00884838099487 | K193215 | 000 |
| 00884838099494 | K193215 | 000 |
| 00884838099500 | K193215 | 000 |
| 00884838098275 | K193215 | 000 |
| 00884838098299 | K193215 | 000 |
| 00884838098312 | K193215 | 000 |
| 00884838098329 | K193215 | 000 |
| 00884838098336 | K193215 | 000 |
| 00884838098343 | K193215 | 000 |
| 00884838098350 | K193215 | 000 |
| 00884838099043 | K193215 | 000 |
| 00884838099449 | K193215 | 000 |