K912170 is an FDA 510(k) clearance for the RADIOACTIVE IODINE-125 SOURCES. This device is classified as a Source, Isotope, Sealed, Gold, Titanium, Platinum (Class II - Special Controls, product code IWI).
Submitted by Best Industries (Springfield, US). The FDA issued a Cleared decision on August 9, 1991, 85 days after receiving the submission on May 16, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K912170 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1991 |
| Decision Date | August 09, 1991 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IWI — Source, Isotope, Sealed, Gold, Titanium, Platinum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |