The following data is part of a premarket notification filed by Icad, Inc. with the FDA for Xoft Axxent Electronic Brachytherapy System Model 110.
| Device ID | K122951 |
| 510k Number | K122951 |
| Device Name: | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 |
| Classification | System, Therapeutic, X-ray |
| Applicant | ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 Nashua, NH 03062 |
| Contact | John A Delucia |
| Correspondent | John A Delucia ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 Nashua, NH 03062 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-25 |
| Decision Date | 2013-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858012005519 | K122951 | 000 |
| 00858012005304 | K122951 | 000 |
| 00858012005298 | K122951 | 000 |
| 00858012005281 | K122951 | 000 |