Cleared Special

GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR

K041922 · General Electric Co. · Radiology
Jul 2004
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K041922 is an FDA 510(k) clearance for the GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on July 28, 2004, 12 days after receiving the submission on July 16, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K041922 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2004
Decision Date July 28, 2004
Days to Decision 12 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZL — System, X-ray, Mobile
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1720

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