Cleared Traditional

K110066 - AQUILION PRIME

K110066 is the FDA 510(k) clearance for AQUILION PRIME by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K110066 · Toshiba America Medical Systems, In.C · Radiology device
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Jan 2012
Decision
381d
Days
Class 2
Risk

K110066 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 Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on January 26, 2012 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K110066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2011
Decision Date January 26, 2012
Days to Decision 381 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
274d slower than avg
Panel avg: 107d · This submission: 381d
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 604
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K110066.
SYNGO CT DYNAMIC ANGIO
K120331 · Siemens AG Medical Solutions · Apr 2012
AQUILION CXL
K112989 · Toshiba America Medical Systems, In.C · Apr 2012
AQUILION PRIME
K120710 · Toshibamedical Systems Corporation · Apr 2012
SAFIRE
K103424 · Siemens Medical Solutions USA, Inc. · Nov 2011
GE VEO RECONSTRUCTION OPTION
K103489 · General Electric Co. · Sep 2011
AQUILION LB MOVEMENT BASE KIT
K111633 · Toshiba America Medical Systems, In.C · Aug 2011