The following data is part of a premarket notification filed by Xoft, Inc. with the FDA for Axxent Electronic Brachytherapy System.
| Device ID | K072683 |
| 510k Number | K072683 |
| Device Name: | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Classification | System, Therapeutic, X-ray |
| Applicant | XOFT, INC. 49000 MILMONT DRIVE Fremont, CA 94538 -7301 |
| Contact | Eric Hashemian |
| Correspondent | Eric Hashemian XOFT, INC. 49000 MILMONT DRIVE Fremont, CA 94538 -7301 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-21 |
| Decision Date | 2008-02-29 |
| Summary: | summary |