The following data is part of a premarket notification filed by Philips Medical Systems Mr Finland with the FDA for Mrcat Brain.
| Device ID | K193109 |
| 510k Number | K193109 |
| Device Name: | MRCAT Brain |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Philips Medical Systems MR Finland Ayritie 4 Vantaa, FI 01510 |
| Contact | Janne Marvola |
| Correspondent | Janne Marvola Philips Medical Systems MR Finland 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 | 2019-11-08 |
| Decision Date | 2020-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838098206 | K193109 | 000 |
| 00884838094093 | K193109 | 000 |