Cleared Traditional

K130645 - AQUILION PRIME

K130645 is the FDA 510(k) clearance for AQUILION PRIME by Toshibamedical Systems Corporation. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K130645 · Toshibamedical Systems Corporation · Radiology device
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Jun 2013
Decision
87d
Days
Class 2
Risk

K130645 is an FDA 510(k) clearance for the AQUILION PRIME, V5.00. 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 June 6, 2013 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toshibamedical Systems Corporation devices

Submission Details

510(k) Number K130645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2013
Decision Date June 06, 2013
Days to Decision 87 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 faster than avg
Panel avg: 107d · This submission: 87d
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
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