Product code ONL— Radiology
RIC CONFORMAL SOURCE, MODEL 100
- Classification name
- Conformal Brachytherapy Source
- Device class
- Class 2
- Regulation
- 21 CFR 892.5730
- Advisory panel
- Radiology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code ONL
FDA has cleared device under product code ONL, all in 2009, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code ONL
Recent clearances under product code ONL
Data sourced from openFDA. This site is unofficial and independent of the FDA.