Conformal Brachytherapy Source
The Conformal Brachytherapy Source (product code ONL) is a Class 2 radiology device regulated under 21 CFR 892.5730 in the Radiology specialty (RA), cleared via 510(k). It contains radioactive material with activity up to 200 mCi and is intended for temporary intraoperative, interstitial, intracavitary, or surface application to treat localized tumors including chordomas, chondrosarcomas, soft tissue sarcomas, skin cancers, and other accessible tumors, and may be used concurrently with or following external beam therapy. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- ONL
- Device Class
- FDA class 2
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Definition
The intended use of the device is for the treatment of cancer by tempeorary intraoperative or surface irradiation. The device contains radioactive material with activity up to 200 mci and is indicated for treatment of temporary intraoperative, interstitial, intracavitary or surface application to treat selected localized tumors. This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy. Chordomas, chondrosarcomas, soft tissue sarcomas, skin cancers and other accessible tumors could be commonly treated by the device.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K090321 | RIC CONFORMAL SOURCE, MODEL 100 | May 27, 2009 | Substantially Equivalent | Ri Consultants, LLC |