The following data is part of a premarket notification filed by Philips Oy with the FDA for Mrcat Head & Neck.
| Device ID | K214081 |
| 510k Number | K214081 |
| Device Name: | MRCAT Head & Neck |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Philips Oy Ayritie 4 Vantaa, FI 01510 |
| Contact | Janne Marvola |
| Correspondent | Anne-Sophie Glantenay Philips Oy Ayritie 4 Vantaa, FI 01510 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838107311 | K214081 | 000 |
| 00884838112742 | K214081 | 000 |
| 00884838122123 | K214081 | 000 |