The following data is part of a premarket notification filed by Xoft, Inc. with the FDA for Axxent Electronic Brachytherapy System.
| Device ID | K050843 |
| 510k Number | K050843 |
| Device Name: | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Classification | System, Therapeutic, X-ray |
| Applicant | XOFT, INC. 49000 MILMONT DRIVE Fremont, CA 94538 |
| Contact | Kathy O'shaughnessy |
| Correspondent | Kathy O'shaughnessy XOFT, INC. 49000 MILMONT DRIVE Fremont, CA 94538 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-01 |
| Decision Date | 2005-12-22 |
| Summary: | summary |