510(k) K100552
K100552 is an FDA 510(k) premarket notification submitted by Raysearch Laboratories AB for the device "RAYSTATION VERSION 1.0". The FDA issued a decision of Substantially Equivalent on March 12, 2010. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Raysearch Laboratories AB has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2010
- Date Received
- February 26, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Planning, Radiation Therapy Treatment
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type