Cleared Traditional

K123500 - AQUILION LB TRITON V4.91

K123500 is an FDA 510(k) clearance for AQUILION LB TRITON V4.91, manufactured by Toshibamedical Systems Corporation. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K123500

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.

JAK Device Classification - Class 2, Special Controls

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 727
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K123500.
ICT
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K123509 · Hitachi Medical Systems America, Inc. · Mar 2013
SYNGO, CT BONE READING
K123584 · Siemens Medical Solutions USA, Inc. · Mar 2013