CT/ MR Tandem and Ovoid Set
FDA 510(k) K250299 · Varian Medical Systems, Inc.
510(k) numberK250299
Submission
- Device name
- CT/ MR Tandem and Ovoid Set
- Applicant
- Varian Medical Systems, Inc.
Palo Alto, CA, US - Received
- January 31, 2025
- Decision date
- May 9, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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| K252884 | Guided Aarhus Applicator SetJAQ · Traditional | 11/19/2025SE |
Questions and answers
When was CT/ MR Tandem and Ovoid Set cleared by the FDA?
CT/ MR Tandem and Ovoid Set (K250299) received a 510(k) decision of Substantially Equivalent on May 9, 2025, 98 days after the submission was received.
What is the product code of K250299?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.