Cleared Abbreviated

K142341 - X-RAY TV SYSTEM SONIALVISION G4

K142341 is the FDA 510(k) clearance for X-RAY TV SYSTEM SONIALVISION G4 by Shimadzu Corp.. It is a Class 2 Radiology device (product code JAA) cleared through the Abbreviated 510(k) pathway after a 197-day FDA review.

K142341 · Shimadzu Corp. · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 2015
Decision
197d
Days
Class 2
Risk

K142341 is an FDA 510(k) clearance for the X-RAY TV SYSTEM SONIALVISION G4. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Shimadzu Corp. (Kyoto, JP). The FDA issued a Cleared decision on March 6, 2015 after a review of 197 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Shimadzu Corp. devices

Submission Details

510(k) Number K142341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 107d · This submission: 197d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 Consultant

Shimadzu Medical Systems
DON KARLE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

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