# K021124: Accufix Tilting Radiotranslucent Headholder

- Pathway: 510(k) (Traditional)
- Applicant: Wfr/Aquaplast Corp.
- Decided: Jul 2, 2002 after 85 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050701: Thigh and Foot Positioner, Suprone Plus, Model RT-6010 (2005), 6 descendants of its own
- K122888: CDR Systems Precision Patient Positioning System (2013), 5 descendants of its own
- K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement (2016), 3 descendants of its own
- K210894: Siddharth-II; Impact (2021), 1 descendant of its own
- K222762: Siddharth-II;Impact (2023), 0 descendants of its own

## Indications for use
The AccuFix Tilting Radiotranslucent Headholder is designed to be used with a head rest or prone pillow and Aquaplast RT Thermoplastic (IC: 935067) masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Headholder attaches to the treatment table, a Silverman brand head rest (for supine treatment) or prone pillow (for prone treatment) is attached to the headholder and a custom fit mask attaches to the headholder in such a way that patient head movement is minimized and the patient's head can be accurately repositioned for subsequent use.

Source page: https://510kreport.com/device/K021124
Methodology: https://510kreport.com/methodology