Cleared Traditional

FDR D-EVO GL Flat Panel Detector System

K152138 · Fujifilm Medical System U.S.A., Inc. · Radiology
Nov 2015
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K152138 is an FDA 510(k) clearance for the FDR D-EVO GL Flat Panel Detector System, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on November 5, 2015, 97 days after receiving the submission on July 31, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K152138 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2015
Decision Date November 05, 2015
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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