The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Mammosite Ii Radiation Therapy System.
| Device ID | K091378 |
| 510k Number | K091378 |
| Device Name: | MAMMOSITE II RADIATION THERAPY SYSTEM |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough, MA 01752 |
| Contact | Jennifer Sullivan |
| Correspondent | Jennifer Sullivan HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough, MA 01752 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-11 |
| Decision Date | 2009-07-02 |
| Summary: | summary |