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Quality Reports

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142142

by Sun Nuclear Corporation

Identifiers

510(k) Number
K142142 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)

Quality Reports is a software-based quality assurance tool designed for linear accelerator systems in radiology. It facilitates the generation and analysis of performance reports to ensure compliance with regulatory standards and operational reliability for medical linear accelerators.

This device is supplied as a digital software solution, intended for use in radiology departments and treatment facilities. It is not classified as single-use or reusable but operates as a standalone software application. The device is cleared under FDA 510(k) (K142142) and falls under Class II regulatory classification, with no specific sterility or MRI safety requirements stated. No physical storage or size specifications are provided beyond its digital nature.

Frequently asked questions

What is the primary purpose of Quality Reports software in a radiology setting?

Quality Reports is designed as a software-based quality assurance tool specifically for linear accelerator systems in radiology. Its main purpose is to generate and analyze performance reports, helping radiology departments ensure compliance with regulatory standards and maintain operational reliability of their medical linear accelerators.

How is Quality Reports supplied and what type of installation is required?

Quality Reports is supplied exclusively as a digital software solution, meaning no physical hardware or installation media is required. It operates as a standalone application, which can be installed on compatible computing systems within radiology departments or treatment facilities.

Is Quality Reports intended for single-use or reusable applications, and how does this affect its maintenance?

Quality Reports is neither single-use nor reusable—it is a standalone software application meant for continuous use. Since it is digital, maintenance involves software updates and system compatibility checks rather than physical replacement or sterilization.

What regulatory pathway was followed for FDA clearance of Quality Reports, and what class does it fall under?

Quality Reports was cleared through the FDA’s 510(k) pathway (K142142) under a traditional review process, with a determination of substantial equivalence. It is classified as a Class II medical device, which indicates moderate regulatory oversight but does not require sterility or MRI safety considerations.

Does Quality Reports require any specific storage conditions, and how is it maintained over time?

As a digital software solution, Quality Reports does not have physical storage requirements like temperature or humidity constraints. Maintenance involves ensuring the host system meets compatibility specifications, applying software updates as provided by the manufacturer, and adhering to standard IT security practices for healthcare 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: Sun Nuclear - Patient Safety Starts Here, Sun Nuclear Quality Reports - allmed.wiki, Sun Nuclear Corporation Device Database - device.report, Independent QA - Sun Nuclear, PDF SUN corporation Nu EA Your Most Valuable QA &

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) K142142 24 fields · synced Sep 19, 2026