Identifiers
- 510(k) Number
- K201058 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Accuvue+ is a Solid State X-Ray Imager (Flat Panel/Digital Imager) used in radiology. It is a software application designed to facilitate the management, distribution, and viewing of radiological digital imaging and communications in medicine (DICOM) image data, including functions for viewing, communication, printing, recording or disc burning, and image manipulation.
The device is supplied as a software application and is authorized under FDA 510(k) clearance (K201058). It is substantially equivalent to a predicate device and is intended for use in radiological imaging workflows. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or specific clinical settings is provided in the data.
Frequently asked questions
What is Accuvue+ used for?
Accuvue+ is a software application designed to facilitate the management, distribution, and viewing of radiological DICOM image data. It supports functions such as viewing, communication, printing, recording or disc burning, and image manipulation in radiology workflows.
How is Accuvue+ supplied and what type of device is it?
Accuvue+ is supplied as a software application and is classified as a Solid State X-Ray Imager (Flat Panel/Digital Imager). It is a digital imaging tool used in radiology for handling DICOM-compliant image data.
Is Accuvue+ a single-use or reusable device?
As a software application, Accuvue+ does not have physical components that are used or consumed in a clinical procedure. Therefore, the concepts of single-use or reusable status do not apply to this type of device.
What regulatory authorization does Accuvue+ have?
Accuvue+ is authorized under FDA 510(k) clearance (K201058) and is determined to be substantially equivalent to a predicate device. It is classified as a Class II medical device under the regulation number 892.1680.
Are there any size, storage, or sterility specifications for Accuvue+?
No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the device data, as Accuvue+ is a software application and does not involve physical hardware with such requirements.
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: Radmedix AccuVue+ 00810035220379 Medical Device Identification, PDF Radmedix LLC May 6, 2020 ℅ Daniel Kamm Principal Engineer 8870 Ravello ..., Accuvue+ (K201058) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201058 | Class II | Active |
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Manufacturer
- Manufacturer
- Radmedix, LLC
Sources (1)
- FDA 510(k) K201058 24 fields · synced Sep 27, 2026