# K991523: TLC Pediatric Frame, Model TLC-Sys

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Jul 30, 1999 after 88 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.
No later device cites it as a predicate yet.
0 of 2 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 1.

## Indications for use
The TLC Frame is indicated for use as a stereotactic platform for fractionated (multiple, lower dose) LINAC-based radiation treatments and related CT and angiographic imaging in the cranium for the treatment of pediatric patients.

Source page: https://510kreport.com/device/K991523
Methodology: https://510kreport.com/methodology