510(k) K222312
K222312 is an FDA 510(k) premarket notification submitted by RaySearch Laboratories AB (PUBL) for the device "RayStation 12A". The FDA issued a decision of Substantially Equivalent on March 29, 2023. 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 (PUBL) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2023
- Date Received
- August 1, 2022
- 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