510(k) K180308
K180308 is an FDA 510(k) premarket notification submitted by Medcom GmbH for the device "Prelude". The FDA issued a decision of Substantially Equivalent on March 27, 2018. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Medcom GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2018
- Date Received
- February 2, 2018
- 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