510(k) K193109
K193109 is an FDA 510(k) premarket notification submitted by Philips Medical Systems MR Finland for the device "MRCAT brain". The FDA issued a decision of Substantially Equivalent on Jan 24, 2020. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Philips Medical Systems MR Finland has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 24, 2020
- Date Received
- Nov 8, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Planning, Radiation Therapy Treatment
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type
- 510(k)