Cleared Traditional

K153464 - FDR D-EVO flat Panel Detector System

K153464 is the FDA 510(k) clearance for FDR D-EVO flat Panel Detector System by Fujifilm Medical Systems U.S.A, Inc.. It is a Class 2 Radiology device (product code MQB) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K153464 · Fujifilm Medical Systems U.S.A, Inc. · Radiology device
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Apr 2016
Decision
129d
Days
Class 2
Risk

K153464 is an FDA 510(k) clearance for the FDR D-EVO 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 Systems U.S.A, Inc. (Stamford, US). The FDA issued a Cleared decision on April 8, 2016 after a review of 129 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 Systems U.S.A, Inc. devices

Submission Details

510(k) Number K153464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2015
Decision Date April 08, 2016
Days to Decision 129 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
22d slower than avg
Panel avg: 107d · This submission: 129d
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 218
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K152138 · Fujifilm Medical System U.S.A., Inc. · Nov 2015