Cleared Traditional

K142003 - FDR D-EVO II FLAT PANEL DETECTOR SYSTEM

K142003 is an FDA 510(k) clearance for FDR D-EVO II FLAT PANEL DETECTOR SYSTEM, manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K142003 · Fujifilm Medical System U.S.A., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
90d
Days
Class 2
Risk

K142003 is an FDA 510(k) clearance for the FDR D-EVO II FLAT PANEL DETECTOR SYSTEM. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on October 21, 2014 after a review of 90 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 Fujifilm Medical System U.S.A., Inc. devices

FDA 510(k) Submission Details - K142003

510(k) Number K142003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2014
Decision Date October 21, 2014
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 390
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K142003.
Radlink GPS
K142718 · Radlink, Inc. · Dec 2014
PerkinElmer, XRpad 4343 F MED Flat Panel Detector
K142698 · Perkinelmer, Inc. · Oct 2014
UNIVERSAL DIGITAL INTERFACE 2, UDI 2
K140251 · Meridian Medical Systems, LLC · Oct 2014
DX-D IMAGING PACKAGE
K142184 · Agfa Healthcare N.V. · Oct 2014
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
K141743 · Radiology Solutions, LLC · Oct 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K141765 · Fujifilm Medical Systems U.S.A, Inc. · Oct 2014