Gammamed Plus 3/24 HDR Remote Afterloader
FDA 510(k) K031524 · Varian Medical Systems, Inc.
510(k) numberK031524
Submission
- Device name
- Gammamed Plus 3/24 HDR Remote Afterloader
- Applicant
- Varian Medical Systems, Inc.
Palo Alto, CA, US - Received
- May 15, 2003
- Decision date
- November 26, 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 Plus 3/24 HDR Remote Afterloader cleared by the FDA?
Gammamed Plus 3/24 HDR Remote Afterloader (K031524) received a 510(k) decision of Substantially Equivalent on November 26, 2003, 195 days after the submission was received.
What is the product code of K031524?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.