510(k) K910648
K910648 is an FDA 510(k) premarket notification submitted by Radiation Technology, Inc. for the device "THERAPY CHAIR SYSTEM". The FDA issued a decision of Substantially Equivalent on July 22, 1991. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Radiation Technology, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 1991
- Date Received
- February 14, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Couch, Radiation Therapy, Powered
- Device Class
- Class II
- Regulation Number
- 892.5770
- Review Panel
- RA
- Submission Type