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Uni-Frame Head Immobilization System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K933227

by Medtec LLC

Identifiers

510(k) Number
K933227 FDA 510(k)
FDA Product Code
IYE 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 Uni-Frame Head Immobilization System is a Class II medical device designed to secure and stabilize a patient’s head during imaging procedures. It ensures precise positioning and minimizes movement, which is critical for accurate diagnostic radiology scans, particularly in linear accelerator applications.

This system is intended for single-use in radiology settings and has received FDA 510(k) clearance under the traditional review pathway. Supplied sterile, it adheres to regulatory standards outlined in 21 CFR 892.5050 and is classified under product code IYE. The device is manufactured by Medtec, Inc., and was cleared in 1994.

Frequently asked questions

What is the primary purpose of the Uni-Frame Head Immobilization System in clinical settings?

The Uni-Frame Head Immobilization System is designed to securely stabilize a patient’s head during imaging procedures, particularly in radiology. This ensures precise positioning and minimizes movement, which is critical for accurate diagnostic radiology scans, especially in linear accelerator applications.

Is the Uni-Frame Head Immobilization System intended for reuse or single-use in radiology settings?

The Uni-Frame Head Immobilization System is explicitly intended for single-use in radiology settings. This design choice aligns with sterile supply standards and reduces the risk of cross-contamination between patients.

How is the Uni-Frame Head Immobilization System supplied, and what does this mean for clinical workflows?

The device is supplied sterile, which means it is pre-sterilized and packaged to maintain sterility until use. This eliminates the need for additional sterilization steps in the clinical workflow, ensuring readiness for immediate application during imaging procedures.

What regulatory pathway was followed for the FDA clearance of this device, and what does this imply about its safety and equivalence?

The Uni-Frame Head Immobilization System received FDA 510(k) clearance under the traditional review pathway, with a decision code of SESE (Substantially Equivalent). This means the FDA determined that the device is substantially equivalent to a legally marketed predicate device in terms of technology and safety, ensuring it meets regulatory standards for use in radiology.

Are there different sizes or models available for the Uni-Frame Head Immobilization System, and if so, how might this affect patient compatibility?

The provided data does not specify variations in sizes or models for the Uni-Frame Head Immobilization System. However, since it is designed for precise head stabilization in radiology, compatibility would depend on standardizing to patient head dimensions. Clinicians should confirm fitment based on manufacturer guidelines or consult Medtec LLC for specific sizing details if needed.

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: UNI-FRAME HEAD IMMOBILIZATION SYSTEM - Innolitics, Medtec Uni-Frame Head Immobilization - allmed.wiki, UNI-FRAME HEAD IMMOBILIZATION SYSTEM 510 (k) K933227 - FDA.report, Uni-frame Thermoplastics | CQ Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtec LLC
FDA Applicant
Medtec, Inc.

Sources (1)

  • FDA 510(k) K933227 24 fields · synced Sep 19, 2026