K122951 is an FDA 510(k) clearance for the XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110. This device is classified as a System, Therapeutic, X-ray (Class II - Special Controls, product code JAD).
Submitted by Icad, Inc. (Nashua, US). The FDA issued a Cleared decision on January 17, 2013, 114 days after receiving the submission on September 25, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5900.
| 510(k) Number | K122951 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2012 |
| Decision Date | January 17, 2013 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAD - System, Therapeutic, X-ray |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5900 |