K082264 is an FDA 510(k) clearance for the CONTURA LUMEN MARKER. This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II - Special Controls, product code JAQ).
Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on September 12, 2008, 32 days after receiving the submission on August 11, 2008.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.
| 510(k) Number | K082264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | August 11, 2008 |
| Decision Date | September 12, 2008 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAQ — System, Applicator, Radionuclide, Remote-controlled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5700 |