ONL — Conformal Brachytherapy Source Class II
FDA product code ONL covers "Conformal Brachytherapy Source", a Class II medical device regulated under 21 CFR 892.5730. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- ONL
- Device Class
- Class II
- Regulation Number
- 892.5730
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K090321 | ri consultants | RIC CONFORMAL SOURCE, MODEL 100 | May 27, 2009 |