# K150979: CT/MR Compatible M.A.C. Interstitial GYN Template

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: May 31, 2016 after 414 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020176: HDR Miami Applicator, Mick Radio-Nuclear Instruments, Inc. (2002) Summary page 5.
- K993400: HDR Contour TP Template and Implant Accessories, Mick Radio-Nuclear Instruments, Inc. (2000) Summary page 5.

## Indications for use
The CT/MR M.A.C Interstitial GYN Template is indicated for high dose rate irradiation of vaginal, cervical, endometrial and urethral cancers. It is intended to provide a needle guidance system for the introduction of needles and a vaginal obturator into the treatment site.

Source page: https://510kreport.com/device/K150979
Methodology: https://510kreport.com/methodology