INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
Device Facts
| Record ID | K011155 |
|---|---|
| Device Name | INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S |
| Applicant | Ibt, Inc. |
| Product Code | KXK · Radiology |
| Decision Date | Jul 12, 2001 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 892.5730 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
