CT/ MR Tandem and Ovoid Set
Varian Medical Systems, Inc.The CT/MR Tandem and Ovoid Set by Varian Medical Systems is a gynecological brachytherapy applicator that is used to treat cancers of the uterus, cervix, paracervix, endometrium, and vagina via HDR brachytherapy. The device is designed to be compatible with CT and MRI imaging, helping clinicians accurately deliver radioactive sources for cancer treatment. It improves patient care by ensuring precise radiation placement and is safe for MR environments.
Intended Use
The CT/MR Tandem and Ovoid Set is a gynecological brachytherapy applicator intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR Brachytherapy.
Technology
The CT/MR Tandem and Ovoid Set is an applicator for intracavitary and interstitial HDR brachytherapy using gamma rays from a radioactive source guided by the device to the treatment area. The device is inserted into the patient and connected to a remote afterloader which controls the source placement. The device is MR safe and CT compatible, made of non-metallic, non-conductive materials, and designed for repeated use after steam sterilization.
Performance
Performance testing included biocompatibility tests compliant with ISO standards, MR compatibility testing confirming MR safety, cleaning and sterilization testing validating repeated use, and mechanical and acoustic design verification. Human factors validation ensured safe operation by intended users. Testing met FDA Quality System and relevant ISO standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/31/2025
3 months - 2
FDA Approval
5/9/2025
Other devices from Varian Medical Systems, Inc.
- Mobius3D (4.1)2025 • 510K
- Intracavitary/Interstitial System2025 • 510K
- Identify (4.0)2025 • 510K
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