Cleared Traditional

K123500 - AQUILION LB TRITON V4.91

K123500 is the FDA 510(k) clearance for AQUILION LB TRITON V4.91 by Toshibamedical Systems Corporation. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K123500 · Toshibamedical Systems Corporation · Radiology device
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May 2013
Decision
170d
Days
Class 2
Risk

K123500 is an FDA 510(k) clearance for the AQUILION LB TRITON V4.91. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Toshibamedical Systems Corporation (Tustin, US). The FDA issued a Cleared decision on May 2, 2013 after a review of 170 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Toshibamedical Systems Corporation devices

Submission Details

510(k) Number K123500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2012
Decision Date May 02, 2013
Days to Decision 170 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
63d slower than avg
Panel avg: 107d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 586
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K123500.
OPTIMA CT660
K131576 · Ge Medical Systems, LLC · Aug 2013
SURESUBTRACTION ORTHO
K130960 · Toshibamedical Systems Corporation · Aug 2013
AQUILION PRIME, V5.00
K130645 · Toshibamedical Systems Corporation · Jun 2013
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM
K123509 · Hitachi Medical Systems America, Inc. · Mar 2013
SYNGO, CT BONE READING
K123584 · Siemens Medical Solutions USA, Inc. · Mar 2013
SYNGO, CT CARDIAC FUNCTION
K123585 · Siemens Medical Solutions USA, Inc. · Dec 2012