Cleared Special

K103596 - WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR

K103596 is an FDA 510(k) clearance for WIRELESS/WIRED FDR D-EVO FLAT PANEL DET..., manufactured by Fujifilm Medical Systems U.S.A, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 111-day FDA review.

K103596 · Fujifilm Medical Systems U.S.A, Inc. · Radiology device
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Mar 2011
Decision
111d
Days
Class 2
Risk

K103596 is an FDA 510(k) clearance for the WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Stamford, US). The FDA issued a Cleared decision on March 29, 2011 after a review of 111 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fujifilm Medical Systems U.S.A, Inc. devices

FDA 510(k) Submission Details - K103596

510(k) Number K103596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2010
Decision Date March 29, 2011
Days to Decision 111 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
4d slower than avg
Panel avg: 107d · This submission: 111d
Pathway characteristics
Modification to existing cleared device.

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 392
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