3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90
FDA 510(k) K150839 · Varian Medical Systems, Inc.
510(k) numberK150839
Submission
- Device name
- 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90
- Applicant
- Varian Medical Systems, Inc.
Palo Alto, CA, US - Received
- March 30, 2015
- Decision date
- July 17, 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 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 cleared by the FDA?
3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 (K150839) received a 510(k) decision of Substantially Equivalent on July 17, 2015, 109 days after the submission was received.
What is the product code of K150839?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.