# K091154: Utrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270, Interstitial Ring CT/MR Applicator Set,Model 110.330,

- Pathway: 510(k) (Special)
- Applicant: Nucletron Corporation
- Decided: May 18, 2009 after 27 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: 3 generations back to K864210 (1986). 4 ancestors in all.
4 later devices descend from it; 3 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)
- K983341: Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set, Fletcher Williamson Applicator SE, Nucletron Corp. (1999) Summary page 1.

## Most influential descendants
- K201272: Geneva (2020), 1 descendant of its own
- K250289: Intracavitary/Interstitial System (2025), 0 descendants of its own
- K180069: HDR MRI Lumen Marker (2018), 0 descendants of its own
- K161688: Advanced Gynecological Applicator (2017), 0 descendants of its own

## Indications for use
The intended use of the device is gynecological brachytherapy procedures for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.

Source page: https://510kreport.com/device/K091154
Methodology: https://510kreport.com/methodology