# 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

- Pathway: 510(k) (Traditional)
- Applicant: Qfix
- Decided: Dec 4, 2015 after 109 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 K032156 (2003). 1 ancestor in all.
1 later device descends 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)
- K032156: Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head Board with Shoulder Depression, Accufix Radiolucent, Wfr/Aquaplast Corp. (2003) Summary page 6.

## Most influential descendants
- K182189: Encompass SRS Headframe ; Encompass MR SRS Headframe (2018), 0 descendants of its own

## Indications for use
The Encompass™ SRS Immobilization System provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient’s features to provide accurate, reproducible positioning, repositioning and immobilization. The Encompass™ SRS Immobilization System allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

Source page: https://510kreport.com/device/K152321
Methodology: https://510kreport.com/methodology