Cleared Special

K120710 - AQUILION PRIME

K120710 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 Special 510(k) pathway after a 29-day FDA review.

K120710 · Toshibamedical Systems Corporation · Radiology device
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Apr 2012
Decision
29d
Days
Class 2
Risk

K120710 is an FDA 510(k) clearance for the AQUILION PRIME. 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 April 6, 2012 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Toshibamedical Systems Corporation devices

Submission Details

510(k) Number K120710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2012
Decision Date April 06, 2012
Days to Decision 29 days
Submission Type Special
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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K120710.
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AQUILION PRIME
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SAFIRE
K103424 · Siemens Medical Solutions USA, Inc. · Nov 2011
GE VEO RECONSTRUCTION OPTION
K103489 · General Electric Co. · Sep 2011