The following data is part of a premarket notification filed by Icad, Inc. with the FDA for Xoft Axxent Cervical Applicators.
| Device ID | K123442 |
| 510k Number | K123442 |
| Device Name: | XOFT AXXENT CERVICAL APPLICATORS |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| 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 | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-08 |
| Decision Date | 2013-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858012005557 | K123442 | 000 |
| 00858012005540 | K123442 | 000 |
| 00858012005533 | K123442 | 000 |