The following data is part of a premarket notification filed by Philips Medical Systems Mr Finland with the FDA for Mrcat.
| Device ID | K151435 |
| 510k Number | K151435 |
| Device Name: | MRCAT |
| 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 | 2015-05-28 |
| Decision Date | 2016-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838084667 | K151435 | 000 |