# K122840: CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Dec 14, 2012 after 88 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). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 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 1.

## 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
- K142597: Vienna System (2015), 0 descendants of its own

## Indications for use
The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is indicated for High Dose Rate irradiation of the uterus and cervix. The modification that precipitated this Special 510(k) does not alter the indications for use.

Source page: https://510kreport.com/device/K122840
Methodology: https://510kreport.com/methodology