Cleared Abbreviated

X-RAY TV SYSTEM SONIAL VISION G4

K131075 · Shimadzu Corp. · Radiology
Mar 2014
Decision
345d
Days
Class 2
Risk

About This 510(k) Submission

K131075 is an FDA 510(k) clearance for the X-RAY TV SYSTEM SONIAL VISION G4, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on March 28, 2014, 345 days after receiving the submission on April 17, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K131075 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2013
Decision Date March 28, 2014
Days to Decision 345 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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