IWA · Source, Wire, Iridium, Radioactive
Radiology · 21 CFR 892.5730 · Class 2
Overview
| Product Code | IWA |
|---|---|
| Device Name | Source, Wire, Iridium, Radioactive |
| Regulation | 21 CFR 892.5730 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
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 (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K915253 | IR-192 IMPLANT, MODIFICATION | Omnitron Intl., Inc. | Feb 27, 1992 | SESE |
| K894409 | CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD | Amersham Corp. | Sep 29, 1989 | SESE |
| K874895 | IR-192 IMPLANT | Rads S.L., Inc. | Feb 25, 1988 | SESE |
| K850382 | IRIDIUM SEEDS | Radiation Safety & Nuclear Products, Inc. | Aug 15, 1985 | SESE |
| K844248 | IR-192 IMPLANT | Rads S.L., Inc. | Apr 10, 1985 | SESE |
| K850726 | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD | Syncor Intl. Corp. | Mar 26, 1985 | SESE |
| K850163 | IRIDIUM 192 WIRES | Syncor Intl. Corp. | Mar 26, 1985 | SESE |
| K771878 | IRIDIUM 192 WIRES & PINS | Cis Radiopharmaceuticals, Inc. | Oct 27, 1977 | SESE |
Top Applicants
- Syncor Intl. Corp. — 2 clearances
- Rads S.L., Inc. — 2 clearances
- Radiation Safety & Nuclear Products, Inc. — 1 clearance
- Omnitron Intl., Inc. — 1 clearance
- Cis Radiopharmaceuticals, Inc. — 1 clearance
