Cleared Traditional

K172682 - Edge Digital Flat Panel X-ray Detector

K172682 is an FDA 510(k) clearance for Edge Digital Flat Panel X-ray Detector, manufactured by Osko, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K172682 · Osko, Inc. · Radiology device
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Oct 2017
Decision
30d
Days
Class 2
Risk

K172682 is an FDA 510(k) clearance for the Edge 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 October 6, 2017 after a review of 30 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osko, Inc. devices

FDA 510(k) Submission Details - K172682

510(k) Number K172682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2017
Decision Date October 06, 2017
Days to Decision 30 days
Submission Type Traditional
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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

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

Mtechgroup
Dave Kim

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 376
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K172682.
Aquarius 8600 1417TG and Aquarius 8600 1717TG
K171169 · Imaging Dynamics Company , Ltd. · Oct 2017
SKR 3000
K172793 · Konica Minolta, Inc. · Oct 2017
Edge Air Digital Flat Panel X-ray Detector
K172681 · Osko, Inc. · Oct 2017
Aquarius 8600 1417WC
K171175 · Imaging Dynamics Company , Ltd. · Oct 2017
CareView 1800Cw X-ray Flat Panel Detectors
K172581 · Careray Digital Medical System Co., Ltd. · Sep 2017
SKR 3000
K171716 · Konica Minolta, Inc. · Aug 2017