Cleared Special

K141895 - MOBILEDIAGNOST WDR

K141895 is an FDA 510(k) clearance for MOBILEDIAGNOST WDR, manufactured by Sedecal., Sa.. The device is a Class 2 Radiology device with product code IZL cleared through the Special 510(k) pathway after a 66-day FDA review.

K141895 · Sedecal., Sa. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
66d
Days
Class 2
Risk

K141895 is an FDA 510(k) clearance for the MOBILEDIAGNOST WDR. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Sedecal., Sa. (Seneca, US). The FDA issued a Cleared decision on September 18, 2014 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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.

FDA 510(k) Submission Details - K141895

510(k) Number K141895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2014
Decision Date September 18, 2014
Days to Decision 66 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
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 236
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K141895.
KUBTEC X250
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AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR
K122298 · Ajex Meditech., Ltd. · Mar 2014
PORTA 100HF
K122697 · Job Corporation · Oct 2012
K141895 · MOBILEDIAGNOST WDR
Download PDF FDA Summary Sedecal., Sa.