VariSeed 9.0
FDA 510(k) K150636 · Varian Medical Systems, Inc.
510(k) numberK150636
Submission
- Device name
- VariSeed 9.0
- Applicant
- Varian Medical Systems, Inc.
Palo Alto, CA, US - Received
- March 11, 2015
- Decision date
- May 8, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was VariSeed 9.0 cleared by the FDA?
VariSeed 9.0 (K150636) received a 510(k) decision of Substantially Equivalent on May 8, 2015, 58 days after the submission was received.
What is the product code of K150636?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.