Cleared Abbreviated

X-RAY TV SYSTEM SONIALVISION G4

K142341 · Shimadzu Corp. · Radiology
Mar 2015
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K142341 is an FDA 510(k) clearance for the X-RAY TV SYSTEM SONIALVISION G4, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Shimadzu Corp. (Kyoto, JP). The FDA issued a Cleared decision on March 6, 2015, 197 days after receiving the submission on August 21, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K142341 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2014
Decision Date March 06, 2015
Days to Decision 197 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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