# K182189: Encompass SRS Headframe ; Encompass MR SRS Headframe

- Pathway: 510(k) (Special)
- Applicant: Qfix
- Decided: Oct 4, 2018 after 52 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: 2 generations back to K032156 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Qfix (2015) Summary page 5.

## Indications for use
The Encompass™ SRS Headframe 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 Headframe 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/K182189
Methodology: https://510kreport.com/methodology