Gammamed 212 and 232 Source Assembly
FDA 510(k) K030745 · Varian Medical Systems
510(k) numberK030745
Submission
- Device name
- Gammamed 212 and 232 Source Assembly
- Applicant
- Varian Medical Systems
Charlottesville, VA, US - Received
- March 10, 2003
- Decision date
- March 12, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Gammamed 212 and 232 Source Assembly cleared by the FDA?
Gammamed 212 and 232 Source Assembly (K030745) received a 510(k) decision of Substantially Equivalent on March 12, 2003, 2 days after the submission was received.
What is the product code of K030745?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.