# K141343: Axxent Cervical Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Icad, Inc.
- Decided: Sep 5, 2014 after 107 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K912555 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040704: Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix Applicator, Mick Radio-Nuclear Instruments, Inc. (2004) Summary page 5.

## Indications for use
The Axxent Cervical Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver high dose rate brachytherapy for intracavitary treatment of cancer of the uterus, cervix, endometrium and vagina.

Source page: https://510kreport.com/device/K141343
Methodology: https://510kreport.com/methodology