The following data is part of a premarket notification filed by Icad, Inc. with the FDA for Axxent Cervical Applicator.
| Device ID | K141343 |
| 510k Number | K141343 |
| Device Name: | AXXENT CERVICAL APPLICATOR |
| Classification | System, Therapeutic, X-ray |
| Applicant | ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 Nashua, NH 03062 |
| Contact | John Delucia |
| Correspondent | John 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 | 2014-05-21 |
| Decision Date | 2014-09-05 |
| Summary: | summary |