# K993400: HDR Contour TP Template and Implant Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Jan 6, 2000 after 90 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: 1 generation back to K811280 (1981). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910862: Various Template Applicators, Best Industries (1991) Summary page 1.
- K811280: Flex-Template, Mick Radio-Nuclear Instruments, Inc. (1981) Summary page 1.
- K933410: Implant Applicators, Cartridges/Magazines, Implanters for Permanent Implant of Radioactive Seeds/Sources, Best Industries (1994) Summary page 1.
- K890341: Mick 200-TP and Mick TP Needle, Mick Radio-Nuclear Instruments, Inc. (1989) Summary page 1.
- K921886: Needle Technologies Seed Implant Needle, Needle Technologies, Inc. (1992) Summary page 1.
- K961601: H.a.M. Applicator, Mick Radio-Nuclear Instruments, Inc. (1996) Summary page 1.
- K904005: Huestis Flexi-Board, Huestis Machine Corp. (1990) Summary page 1.

## Most influential descendants
- K150979: CT/MR Compatible M.A.C. Interstitial GYN Template (2016), 0 descendants of its own
- K031273: Ameritek Sure-Point HDR Needle Template (2003), 0 descendants of its own

## Indications for use
The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modern era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities for this are Low Dose Rate and High Dose Rate remote afterloading. One common use of high dose rate remote afterloaders is in the treatment of cancer of the prostate. The system described in this 510(k) has been developed to work with commercially available high dose rate remote in the treatment of the Prostate.

Source page: https://510kreport.com/device/K993400
Methodology: https://510kreport.com/methodology