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Mapcheck2, Arccheck

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131466

by Sun Nuclear Corporation

Identifiers

510(k) Number
K131466 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 MapCHECK2 and ArcCHECK are quality assurance (QA) devices designed for linear accelerator-based radiotherapy. These devices function as two-dimensional detector arrays used to verify the accuracy of radiation beam delivery in complex treatment plans, including intensity-modulated radiation therapy (IMRT), volumetric modulated arc therapy (VMAT), stereotactic body radiation therapy (SBRT), and magnetic resonance-guided radiation therapy (MRgRT). They provide quantitative measurements of dose distributions, enabling clinicians to detect and correct errors in treatment planning and delivery systems.

These devices are supplied as reusable, non-sterile components intended for use in radiology departments. The MapCHECK2 and ArcCHECK are classified as Class II medical devices under FDA regulations (892.5050) and have received FDA 510(k) clearance (K131466) as substantially equivalent to a predicate device. They are designed for integration with various linear accelerator systems, including those from Varian, Accuray, and other manufacturers. Proper handling, calibration, and storage are required to maintain accuracy and reliability, adhering to manufacturer guidelines and regulatory standards.

Frequently asked questions

What types of radiotherapy treatments are the MapCHECK2 and ArcCHECK designed to verify?

The MapCHECK2 and ArcCHECK are specifically designed to verify the accuracy of radiation beam delivery for complex radiotherapy treatments, including intensity-modulated radiation therapy (IMRT), volumetric modulated arc therapy (VMAT), stereotactic body radiation therapy (SBRT), and magnetic resonance-guided radiation therapy (MRgRT). They provide quantitative dose distribution measurements to help detect and correct errors in treatment planning and delivery systems.

Are the MapCHECK2 and ArcCHECK devices single-use or reusable, and what does this mean for my facility?

The MapCHECK2 and ArcCHECK are reusable devices, meaning they are intended for repeated use within a radiology department. Since they are non-sterile, proper handling, cleaning, calibration, and storage protocols must be followed to maintain accuracy and reliability. The manufacturer provides guidelines to ensure safe reuse and optimal performance.

Which linear accelerator brands and models are compatible with the MapCHECK2 and ArcCHECK?

The MapCHECK2 and ArcCHECK are designed for integration with multiple linear accelerator systems, including those from Varian and Accuray, among other manufacturers. While the exact compatibility list isn’t detailed here, their broad approval under FDA 510(k) clearance (K131466) suggests they are intended for general use with common radiotherapy platforms. Always verify compatibility with your specific system before use.

How should I store the MapCHECK2 or ArcCHECK to ensure they remain accurate and functional?

Since these devices are reusable and non-sterile, they must be stored in a clean, controlled environment to prevent damage or contamination. The manufacturer recommends adhering to their guidelines for proper handling, calibration, and storage to maintain accuracy and reliability. Avoid exposure to extreme temperatures, humidity, or physical stress, as these could compromise performance.

What regulatory pathway was followed for FDA clearance of the MapCHECK2 and ArcCHECK?

The MapCHECK2 and ArcCHECK received FDA 510(k) clearance under the traditional review pathway, classified as substantially equivalent to a predicate device. The clearance was granted by the FDA’s Radiology (RA) Advisory Committee and falls under product code IYE (Linear Accelerators). The decision was made on August 20, 2013, following a review process initiated on May 21, 2013.

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: ArcCHECK® - Sun Nuclear, PDF ArcCHECK® - Sun Nuclear, Sun Nuclear Mapcheck2, Arccheck - allmed.wiki, PDF SUN EARYour Nua Most Valu able QA & Dosimetry Tools corporation

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sun Nuclear Corporation

Sources (1)

  • FDA 510(k) K131466 24 fields · synced Sep 20, 2026