MAASTRO Rectal Applicator Set— 510(k) K252717
Substantially EquivalentVarian Medical Systems
FDA 510(k) clearance K252717 for MAASTRO Rectal Applicator Set, Substantially Equivalent on 2026-05-20. Applicant: Varian Medical Systems. Device class: 2.
Summary
Varian Medical Systems filed the MAASTRO Rectal Applicator Set under JAQ, remote-controlled radionuclide applicator systems.
Class II, 21 CFR 892.5700. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
Varian filed from Palo Alto, California. The decision came 265 calendar days after receipt (August 28, 2025 to May 20, 2026).
Clearance details
- Applicant
- Varian Medical Systems
- Product code
- Product code JAQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5700
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
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