# K934523: Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1)

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Feb 8, 1995 after 509 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
No predicates in its family tree.
32 later devices descend from it; 6 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960338: Stereotactic Body Frame (1996), 13 descendants of its own
- K970291: Accessories to the Stereotactic Body Fram (1997), 9 descendants of its own
- K982463: Extracranial Radiotherapy System (1998), 8 descendants of its own
- K962155: Gill-Thomas-Cosman (GTC) Dental Tray (1996), 8 descendants of its own
- K991336: Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy (1999), 7 descendants of its own

Source page: https://510kreport.com/device/K934523
Methodology: https://510kreport.com/methodology