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360 Deg. Rotating 1/2 Beam Block

FDA 510(k)

Class II (US FDA 510(k))

510(k) K941719

by Medtec LLC

Identifiers

510(k) Number
K941719 FDA 510(k)
FDA Product Code
IXI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5710 FDA 510(k)
Regulation Number
892.5710 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 360 Degree Rotating Half-Beam Block is a beam-shaping device used in radiation therapy. It is designed to modify the shape of a radiation beam by blocking half of its cross-section, enabling precise dose distribution during treatment. This device falls under the classification of Block, Beam-Shaping, Radiation Therapy as defined by regulatory authorities.

This device is intended for use in radiology settings and is classified as a Class II medical device. It is supplied as a reusable component, with no indication of sterility requirements in the provided data. The device is authorized under FDA 510(k) clearance (K941719) and adheres to regulation 892.5710. No specific MRI safety information or size variations are noted in the available specifications.

Frequently asked questions

What is the primary purpose of the 360 Degree Rotating 1/2 Beam Block in radiation therapy?

The 360 Degree Rotating 1/2 Beam Block is designed to modify the shape of a radiation beam by blocking half of its cross-section. This allows for precise control over dose distribution during radiation therapy, ensuring targeted treatment while minimizing exposure to surrounding healthy tissue.

Is this device intended for single-use or reusable applications in clinical settings?

This device is explicitly supplied as a reusable component, meaning it is intended for repeated use in clinical settings after proper cleaning and maintenance. There is no mention of sterility requirements in the provided data, so adherence to facility-specific reprocessing protocols is necessary.

How was the regulatory approval for this device obtained, and what does that mean for its use?

The device received FDA clearance through a 510(k) submission (K941719), classified as substantially equivalent to a predicate device. This means the FDA determined it meets the same performance standards as an existing approved device, allowing it to be legally marketed and used in radiology settings for its intended purpose.

Are there any variations in size or model for this beam-shaping device?

The provided data does not specify any size variations or distinct model numbers for the 360 Degree Rotating 1/2 Beam Block. However, the registration numbers listed under OpenFDA suggest multiple units may be tracked, but no details on differences in design or dimensions are available.

What type of facility or department would typically use this device?

This device is intended for use in radiology departments within healthcare facilities, specifically for radiation therapy applications. Its classification as a Class II medical device and the regulatory specialty designation of *Radiology* confirm its role in controlled radiation treatment environments.

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: 360 DEG. ROTATING 1/2 BEAM BLOCK - fda.innolitics.com, Medtec 360 Deg. Rotating 1/2 Beam Block - allmed.wiki, 360 DEG. ROTATING 1/2 BEAM BLOCK 510(k) K941719 - FDA.report, PDF K941719 360 DEG. ROTATING 1/2 BEAM BLOCK - 510kdatabase.net, Establishment Registration & Device Listing

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) K941719 24 fields · synced Sep 19, 2026