510(k) K153368
K153368 is an FDA 510(k) premarket notification submitted by Gmv Soluciones Globales Internet S.A.U. for the device "Radiance V3". The FDA issued a decision of Substantially Equivalent on February 16, 2016. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Gmv Soluciones Globales Internet S.A.U. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2016
- Date Received
- November 23, 2015
- 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