510(k) K192065
K192065 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "Syngo.Via RT Image Suite". The FDA issued a decision of Substantially Equivalent on Sep 18, 2019. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Siemens Medical Solutions USA, Inc. has 783 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 18, 2019
- Date Received
- Aug 1, 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)