The following data is part of a premarket notification filed by Philips Medical Systems Mr Finland with the FDA for Mrcat Pelvis.
Device ID | K182888 |
510k Number | K182888 |
Device Name: | MRCAT Pelvis |
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 | 2018-10-15 |
Decision Date | 2019-04-30 |