Cleared Special

K201503 - Edge Air(1417) Digital Flat Panel X-ray...

K201503 is the FDA 510(k) clearance for Edge Air(1417) Digital Flat Panel X-ray... by Osko, Inc.. It is a Class 2 Radiology device (product code MQB) cleared through the Special 510(k) pathway after a 24-day FDA review.

K201503 · Osko, Inc. · Radiology device
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Jun 2020
Decision
24d
Days
Class 2
Risk

K201503 is an FDA 510(k) clearance for the Edge Air(1417) Digital Flat Panel X-ray Detector. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Osko, Inc. (Miami, US). The FDA issued a Cleared decision on June 29, 2020 after a review of 24 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 Osko, Inc. devices

Submission Details

510(k) Number K201503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2020
Decision Date June 29, 2020
Days to Decision 24 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
83d faster than avg
Panel avg: 107d · This submission: 24d
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 Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 218
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K201503.
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Accuvue+
K201058 · Radmedix, LLC · May 2020