K081066 is an FDA 510(k) clearance for the BRACHYTHERAPY SOURCE DEVICE, MODEL 9011. This device is classified as a Seed, Isotope, Gold, Titanium, Platinum (Class II - Special Controls, product code IWG).
Submitted by Medi-Physics, Inc., Dba GE Healthcare (Princeton, US). The FDA issued a Cleared decision on May 5, 2008, 20 days after receiving the submission on April 15, 2008.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K081066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2008 |
| Decision Date | May 05, 2008 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IWG — Seed, Isotope, Gold, Titanium, Platinum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |