K091378 is an FDA 510(k) clearance for the MAMMOSITE II RADIATION THERAPY SYSTEM. This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II - Special Controls, product code JAQ).
Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Cleared decision on July 2, 2009, 52 days after receiving the submission on May 11, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.
| 510(k) Number | K091378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | May 11, 2009 |
| Decision Date | July 02, 2009 |
| Days to Decision | 52 days |
| Submission Type | Special |
| 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 |