The following data is part of a premarket notification filed by Xoft, Inc. with the FDA for Axxent Flexishield Mini.
| Device ID | K090417 |
| 510k Number | K090417 |
| Device Name: | AXXENT FLEXISHIELD MINI |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | XOFT, INC. 345 POTRERO AVE. Sunnyvale, CA 94085 |
| Contact | Steve Lin |
| Correspondent | Steve Lin XOFT, INC. 345 POTRERO AVE. Sunnyvale, CA 94085 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-18 |
| Decision Date | 2009-06-23 |
| Summary: | summary |