Titanium Flexible Geometry FSD Applicator Set (GM11013400)
FDA 510(k) K243939 · Varian Medical Systems, Inc.
510(k) numberK243939
Submission
- Device name
- Titanium Flexible Geometry FSD Applicator Set (GM11013400)
- Applicant
- Varian Medical Systems, Inc.
Palo Alto, CA, US - Received
- December 20, 2024
- Decision date
- March 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Varian Medical Systems, Inc.
| 510(k) | Device | Decision |
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| K261856 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | 08/03/2026SE |
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| K260750 | Virtual Cone (1.0)MUJ · Traditional | 07/08/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | 06/04/2026SE |
| K252717 | MAASTRO Rectal Applicator SetJAQ · Traditional | 05/20/2026SE |
| K252815 | ProBeam 360 Proton Therapy System v3.0LHN · Traditional | 04/23/2026SE |
| K252304 | syngo.via RT Image Suite VC10MUJ · Traditional | 03/18/2026SE |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | 01/21/2026SE |
| K252919 | Identify (5.0)IYE · Traditional | 12/16/2025SE |
| K252884 | Guided Aarhus Applicator SetJAQ · Traditional | 11/19/2025SE |
Questions and answers
When was Titanium Flexible Geometry FSD Applicator Set (GM11013400) cleared by the FDA?
Titanium Flexible Geometry FSD Applicator Set (GM11013400) (K243939) received a 510(k) decision of Substantially Equivalent on March 3, 2025, 73 days after the submission was received.
What is the product code of K243939?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.