510(k) K090321
K090321 is an FDA 510(k) premarket notification submitted by Ri Consultants, LLC for the device "RIC CONFORMAL SOURCE, MODEL 100". The FDA issued a decision of Substantially Equivalent on May 27, 2009. The device falls under product code ONL (Conformal Brachytherapy Source), a Class II device regulated under 21 CFR 892.5730.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 2009
- Date Received
- February 9, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conformal Brachytherapy Source
- Device Class
- Class II
- Regulation Number
- 892.5730
- Review Panel
- RA
- Submission Type
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.