510(k) K142219
K142219 is an FDA 510(k) premarket notification submitted by Best Theratronics Limited for the device "GammaBeam 100". The FDA issued a decision of Substantially Equivalent on November 13, 2014. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Best Theratronics Limited has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2014
- Date Received
- August 12, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Radiation Therapy, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.5750
- Review Panel
- RA
- Submission Type