← Back to catalogue

Encompass SRS Headframe ; Encompass MR SRS Headframe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182189

by Qfix

Identifiers

510(k) Number
K182189 FDA 510(k)
FDA Product Code
IYE FDA 510(k)
Models / Variants
Encompass SRS Headframe FDA 510(k)
Encompass MR SRS Headframe FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Encompass SRS Headframe ; Encompass MR SRS Headframe is a noninvasive stereotactic head and neck immobilization device. It functions as a removable attachment for patient positioning devices that accept S-type thermoplastic masks.

It is a Class 2 Radiology device with product code IYE, cleared through the Special 510(k) pathway under FDA 510(k) number K182189. The device is manufactured by Qfix and is used in radiology settings.

Frequently asked questions

What is the Encompass SRS Headframe used for?

The Encompass SRS Headframe is a noninvasive stereotactic head and neck immobilization device designed to function as a removable attachment for patient positioning devices that accept S-type thermoplastic masks, enabling precise and repeatable patient setup in radiology procedures.

How is the Encompass SRS Headframe supplied and is it reusable?

The Encompass SRS Headframe is supplied as a noninvasive immobilization device intended for use with S-type thermoplastic masks; it is designed as a removable attachment, implying reuse after proper cleaning, though specific reprocessing instructions are not detailed in the provided data.

What regulatory pathway was used for the Encompass SRS Headframe?

The Encompass SRS Headframe was cleared through the Special 510(k) pathway under FDA 510(k) number K182189, indicating it was found substantially equivalent to a predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Encompass SRS Headframe ; Encompass MR SRS Headframe (K182189) — FDA ..., K182189 - Encompass SRS Headframe | FDA 510 (k) | Qfix, Qfix Encompass SRS Headframe Encompass MR SRS Headframe - allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Qfix

Sources (1)

  • FDA 510(k) K182189 24 fields · synced Sep 28, 2026