Cleared Traditional

K132106 - INFINIX ANGIO WORKSTATION W/DTS SOFTWARE

K132106 is an FDA 510(k) clearance for INFINIX ANGIO WORKSTATION W/DTS SOFTWARE, manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K132106 · Toshiba America Medical Systems, In.C · Radiology device
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Nov 2013
Decision
127d
Days
Class 2
Risk

K132106 is an FDA 510(k) clearance for the INFINIX ANGIO WORKSTATION W/DTS SOFTWARE. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on November 12, 2013 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toshiba America Medical Systems, In.C devices

FDA 510(k) Submission Details - K132106

510(k) Number K132106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2013
Decision Date November 12, 2013
Days to Decision 127 days
Submission Type Traditional
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
20d slower than avg
Panel avg: 107d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

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

All 188
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GENESIS
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