IWI · Source, Isotope, Sealed, Gold, Titanium, Platinum
Radiology · 21 CFR 892.5730 · Class 2
Overview
| Product Code | IWI |
|---|---|
| Device Name | Source, Isotope, Sealed, Gold, Titanium, Platinum |
| 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.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973363 | NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 | Ml Strategies, Inc. | Jul 2, 1998 | SESE |
| K940632 | I-125 RAPID STRAND | Medi-Physics Inc. Dba Nycomed Amersham Imaging | Sep 2, 1994 | SESE |
| K912170 | RADIOACTIVE IODINE-125 SOURCES | Best Industries | Aug 9, 1991 | SESE |
| K882449 | CESIUM 137 SOURCE, MODEL CSM-40 | Cis-Us, Inc. | Apr 14, 1989 | SESE |
| K874787 | MODIFIED PALLADIUM SEED MODEL 100 | Theragenics Corp. | Dec 22, 1987 | SESE |
| K852542 | PALLADIUM SEED MODEL 100 | Nuclear Medicine, Inc. | Jan 14, 1986 | SESE |
Top Applicants
- Best Industries — 1 clearance
- Cis-Us, Inc. — 1 clearance
- Medi-Physics Inc. Dba Nycomed Amersham Imaging — 1 clearance
- Ml Strategies, Inc. — 1 clearance
- Nuclear Medicine, Inc. — 1 clearance
