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Accuvue+

by Radmedix, LLC

510(k) K201058

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK201058 Date6 May 2020ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MQB
Device class
Class II
Regulation
21 CFR Part 892.1680
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K201058

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K201058
UDI-DISize and differences
Radmedix AccuVue+ 5
Radmedix, LLC
500810035220379 —On the market

Similar devices

Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

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