Cleared Traditional

K141440 - DICOMPACS DX-R WITH FLAT PANEL (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141440 · Oehm Und Rehbein GmbH · Radiology device
Aug 2014
Decision
88d
Days
Class 2
Risk

K141440 is an FDA 510(k) clearance for the DICOMPACS DX-R WITH FLAT PANEL. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Oehm Und Rehbein GmbH (Naples, US). The FDA issued a Cleared decision on August 29, 2014 after a review of 88 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.

Submission Details

510(k) Number K141440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2014
Decision Date August 29, 2014
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 47
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K141440.
Lux HD 2530 detector (Lux HD 2530)
K252911 · Iray Imaging Technology (Haining) Limited · Oct 2025
Yushan X-Ray Flat Panel Detector
K250211 · Innocare Optoelectronics Corp. · Jul 2025
SKR 3000
K250665 · Konica Minolta, Inc. · Jun 2025
Wireless/ Wired X-Ray Flat Panel Detectors
K243734 · Allengers Medical Systems Limited · Apr 2025
EXPD 114
K242770 · DRTECH Corporation · Mar 2025
EXPD 4343N1
K243443 · DRTECH Corporation · Mar 2025