Cleared Traditional

K141192 - DR 400

K141192 is an FDA 510(k) clearance for DR 400, manufactured by Agfa Healthcare N.V.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K141192 · Agfa Healthcare N.V. · Radiology device
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Jun 2014
Decision
29d
Days
Class 2
Risk

K141192 is an FDA 510(k) clearance for the DR 400. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Agfa Healthcare N.V. (Greenville, US). The FDA issued a Cleared decision on June 6, 2014 after a review of 29 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 Agfa Healthcare N.V. devices

FDA 510(k) Submission Details - K141192

510(k) Number K141192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2014
Decision Date June 06, 2014
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
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 244
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K141192.
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
XGEO GR40CW
K140235 · Samsung Electronics Co., Ltd. · May 2014
DIGITAL DENTAL INTRA ORAL SENSOR
K140056 · Rayence Co., Ltd. · May 2014
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
K140060 · Rayence Co., Ltd. · May 2014