Cleared Special

Accuvue+ (K201058) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201058 · Radmedix, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
15d
Days
Class 2
Risk

K201058 is an FDA 510(k) clearance for the Accuvue+. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Radmedix, LLC (Dayton, US). The FDA issued a Cleared decision on May 6, 2020 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Radmedix, LLC devices

Submission Details

510(k) Number K201058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2020
Decision Date May 06, 2020
Days to Decision 15 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Kamm & Associates
Daniel Kamm

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 146
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K201058.
Edge Air(1417) Digital Flat Panel X-ray Detector
K201503 · Osko, Inc. · Jun 2020
Intraoral Sensor
K201247 · Dentium Co., Ltd (Ict Branch) · Jun 2020
Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
K201043 · Iray Technology Taicang , Ltd. · May 2020
Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W
K201004 · Iray Technology Taicang , Ltd. · May 2020
BSD3543W
K200787 · Bontech Co., Ltd. · Apr 2020
DR-ID 1200SDK System
K200668 · Fujifilm Corporation · Apr 2020