# K032156: Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head Board with Shoulder Depression, Accufix Radiolucent

- Pathway: 510(k) (Traditional)
- Applicant: Wfr/Aquaplast Corp.
- Decided: Sep 2, 2003 after 50 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K152321: kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening (2015), 1 descendant of its own
- K182189: Encompass SRS Headframe ; Encompass MR SRS Headframe (2018), 0 descendants of its own

## Indications for use
The AccuFix Radiolucent Patient Immobilization System is designed to be used with an Aquaplast RT Thermoplastic (K 935067) mold or mask to immobilize, position and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Immobilization Board attaches or mounts to a treatment table or to a Qfix Radiolucent Replacement Couchtop, which in turn mounts to the treatment table. The patient is then positioned on the immobilization board as deemed appropriate by the treating physician. Warm Aquaplast RT Thermoplastic, in its pliable state, is then molded over the patient where it conforms to the patient’s anatomy. As the Aquaplast RT Thermoplastic cools, it becomes rigid, creating a negative mold or mask of the patient’s anatomy. This mold or mask can then be used to minimize patient movement, and accu reposition the patient for subsequent treatment sessions.

Source page: https://510kreport.com/device/K032156
Methodology: https://510kreport.com/methodology