GammaBeam 100
FDA 510(k) K142219 · Best Theratronics Limited
510(k) numberK142219
Submission
- Device name
- GammaBeam 100
- Applicant
- Best Theratronics Limited
Ottawa, CA - Received
- August 12, 2014
- Decision date
- November 13, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was GammaBeam 100 cleared by the FDA?
GammaBeam 100 (K142219) received a 510(k) decision of Substantially Equivalent on November 13, 2014, 93 days after the submission was received.
What is the product code of K142219?
The FDA product code is IWB – System, Radiation Therapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5750.