The following data is part of a premarket notification filed by Xoft, An Icad Company with the FDA for Axxent Radiation Shield - Rigid.
| Device ID | K111299 |
| 510k Number | K111299 |
| Device Name: | AXXENT RADIATION SHIELD - RIGID |
| Classification | System, Therapeutic, X-ray |
| Applicant | XOFT, AN ICAD COMPANY 345 POTRERO AVENUE Sunnyvale, CA 94085 |
| Contact | Steve Lin |
| Correspondent | Steve Lin XOFT, AN ICAD COMPANY 345 POTRERO AVENUE Sunnyvale, CA 94085 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-09 |
| Decision Date | 2011-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858012005403 | K111299 | 000 |
| 00858012005397 | K111299 | 000 |
| 00858012005380 | K111299 | 000 |
| 00858012005373 | K111299 | 000 |
| 00858012005366 | K111299 | 000 |
| 00858012005274 | K111299 | 000 |