# K063382: HDR CT Compatible Split Ring Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Dec 26, 2006 after 48 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- 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 K864210 (1986). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030110: CT HDR Tandem/Ring Applicator with Rectal Retractor, Mick Radio-Nuclear Instruments, Inc. (2003) Summary page 2.
- K011657: HDR Tandem/Ring Applicator with Rectal Retractor, Mick Radio-Nuclear Instruments, Inc. (2001) Summary page 2.
- K961601: H.a.M. Applicator, Mick Radio-Nuclear Instruments, Inc. (1996) Summary page 2.

## Most influential descendants
- K200221: CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor (2020), 0 descendants of its own
- K082530: Applicators for Afterloading Brachytherapy (2008), 0 descendants of its own

## Indications for use
The HDR CT Compatible Split Ring type applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.

Source page: https://510kreport.com/device/K063382
Methodology: https://510kreport.com/methodology