Cleared Traditional

K140825 - DELWORKS DR SYSTEM

K140825 is an FDA 510(k) clearance for DELWORKS DR SYSTEM, manufactured by Del Medical, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K140825 · Del Medical, Inc. · Radiology device
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Jul 2014
Decision
107d
Days
Class 2
Risk

K140825 is an FDA 510(k) clearance for the DELWORKS DR SYSTEM. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Del Medical, Inc. (Naples, US). The FDA issued a Cleared decision on July 17, 2014 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Del Medical, Inc. devices

FDA 510(k) Submission Details - K140825

510(k) Number K140825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2014
Decision Date July 17, 2014
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
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 Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 268
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K140825.
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K141765 · Fujifilm Medical Systems U.S.A, Inc. · Oct 2014
AERODR SYSTEM 2
K141271 · Konica Minolta, Inc. · Sep 2014
DX-D IMAGING PACKAGE
K141602 · Agfa Healthcare N.V. · Sep 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
K141563 · Rayence Co., Ltd. · Jul 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC
K141566 · Rayence Co., Ltd. · Jul 2014
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
K133693 · Canon, Inc. · Jul 2014