ONL · Conformal Brachytherapy Source
Radiology · 21 CFR 892.5730 · Class 2
Overview
| Product Code | ONL |
|---|---|
| Device Name | Conformal Brachytherapy Source |
| Regulation | 21 CFR 892.5730 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.
Classification Rationale
Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K090321 | RIC CONFORMAL SOURCE, MODEL 100 | Ri Consultants, LLC | May 27, 2009 | SESE |
Top Applicants
- Ri Consultants, LLC — 1 clearance
