Cleared Special

K120546 - AQUILION PREMIUM

K120546 is an FDA 510(k) clearance for AQUILION PREMIUM, manufactured by Toshiba Medical Systems Corporation, Japan. The device is a Class 2 Radiology device with product code JAK cleared through the Special 510(k) pathway after a 111-day FDA review.

K120546 · Toshiba Medical Systems Corporation, Japan · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
111d
Days
Class 2
Risk

K120546 is an FDA 510(k) clearance for the AQUILION PREMIUM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Toshiba Medical Systems Corporation, Japan (Tustin, US). The FDA issued a Cleared decision on June 13, 2012 after a review of 111 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120546

510(k) Number K120546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2012
Decision Date June 13, 2012
Days to Decision 111 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
4d slower than avg
Panel avg: 107d · This submission: 111d
Pathway characteristics
Modification to existing cleared device.

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 826
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K120546.
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K120546 · AQUILION PREMIUM
Download PDF FDA Summary Toshiba Medical Syste…