Cleared Traditional

K100762 - FLAT PANEL DETECTOR

K100762 is the FDA 510(k) clearance for FLAT PANEL DETECTOR 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 120-day FDA review.

K100762 · Fujifilm Medical Systems U.S.A, Inc. · Radiology device
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Jul 2010
Decision
120d
Days
Class 2
Risk

K100762 is an FDA 510(k) clearance for the FLAT PANEL DETECTOR, MODEL FDR D-EVO. 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 July 15, 2010 after a review of 120 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 K100762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2010
Decision Date July 15, 2010
Days to Decision 120 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
13d slower than avg
Panel avg: 107d · This submission: 120d
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
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K100762.
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
K103596 · Fujifilm Medical Systems U.S.A, Inc. · Mar 2011
DIGITAL FLAT PANEL X-RAY DETECTOR
K101590 · VATECH Co., Ltd. · Nov 2010
WIRELESS DR IMAGING OPTION-WDR1
K102615 · Ge Medical Systems, LLC · Nov 2010
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
K093427 · Fujifilm Medical System U.S.A., Inc. · Jan 2010
DIGITAL RADIOGRAPHY CXDI-60C
K091545 · Canon, Inc. · Jun 2009
DIGITAL RADIOGRAPHY MODEL CXDI-55G
K091435 · Canon, Inc. · May 2009