The following data is part of a premarket notification filed by Icad Inc. with the FDA for Axxent Electronic Brachytherapy System Model 110 Xp 1200.
| Device ID | K153570 |
| 510k Number | K153570 |
| Device Name: | Axxent Electronic Brachytherapy System Model 110 XP 1200 |
| Classification | System, Therapeutic, X-ray |
| Applicant | ICAD INC. 98 SPITBROOK ROAD, SUITE 100 Nashua, NH 03062 |
| Contact | John Delucia |
| Correspondent | John Delucia ICAD INC. 98 SPITBROOK 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 | 2015-12-14 |
| Decision Date | 2016-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858012005526 | K153570 | 000 |