# K962155: Gill-Thomas-Cosman (GTC) Dental Tray

- Pathway: 510(k) (Traditional)
- Applicant: Radionics Software Applications, Inc.
- Decided: Aug 22, 1996 after 79 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K934523 (1995). 1 ancestor in all.
8 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)
- K934523: Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1), Radionics, Inc. (1995) Summary page 2.

## Most influential descendants
- K153270: TruGuard Custom Tongue and Jaw Positioner (2016), 4 descendants of its own
- K183374: GrayDuck Stent (2019), 2 descendants of its own
- K991237: Xplan-2 with Head and Neck Localizer, Model HNL (1999), 2 descendants of its own
- K081935: Stereotactic Head and Neck Localizer, Model 50-100 (2008), 1 descendant of its own
- K232293: kallisio stentra™ oral stent (2023), 0 descendants of its own

## Indications for use
The Dental Tray holds an impression of the upper teeth, and is part of the GTC Relocatable Head Holder in stereotactic collimated beam, computer planned, LINAC (linear accelerator) based treatment. The Dental Tray holds the dental impression. The dental impression allows repeat positioning of the stereotactic frame at the same location, e.g., for multiple lower dose fractionated stereotactic radiotherapy treatments.

Source page: https://510kreport.com/device/K962155
Methodology: https://510kreport.com/methodology