Cleared Traditional

K112989 - AQUILION CXL

K112989 is an FDA 510(k) clearance for AQUILION CXL, manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K112989 · Toshiba America Medical Systems, In.C · Radiology device
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Apr 2012
Decision
187d
Days
Class 2
Risk

K112989 is an FDA 510(k) clearance for the AQUILION CXL. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on April 10, 2012 after a review of 187 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 Toshiba America Medical Systems, In.C devices

FDA 510(k) Submission Details - K112989

510(k) Number K112989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2011
Decision Date April 10, 2012
Days to Decision 187 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
80d slower than avg
Panel avg: 107d · This submission: 187d
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 731
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K112989.
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
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SYNGO CT DYNAMIC ANGIO
K120331 · Siemens AG Medical Solutions · Apr 2012
AQUILION ONE
K113466 · Toshiba Medical Systems Coporation, Japan · Apr 2012
PEDCAT
K113548 · Curvebeam, LLC · Apr 2012
AQUILION PRIME
K120710 · Toshibamedical Systems Corporation · Apr 2012