510(k) K050422
K050422 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "550 TXT TREATMENT TABLE". The FDA issued a decision of Substantially Equivalent on March 18, 2005. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2005
- Date Received
- February 18, 2005
- Clearance Type
- Special
- 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