Cleared Abbreviated

K093891 - AQUILION ONE VERSION 4.6 W/DUAL ENERGY ...

K093891 is the FDA 510(k) clearance for AQUILION ONE VERSION 4.6 W/DUAL ENERGY ... by Toshibamedical Systems Corporation. It is a Class 2 Radiology device (product code JAK) cleared through the Abbreviated 510(k) pathway after a 335-day FDA review.

K093891 · Toshibamedical Systems Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
335d
Days
Class 2
Risk

K093891 is an FDA 510(k) clearance for the AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2. 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 November 18, 2010 after a review of 335 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Toshibamedical Systems Corporation devices

Submission Details

510(k) Number K093891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2009
Decision Date November 18, 2010
Days to Decision 335 days
Submission Type Abbreviated
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
228d slower than avg
Panel avg: 107d · This submission: 335d
Pathway characteristics
Standards-based clearance path.

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 K093891.
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102102 · VATECH Co., Ltd. · Mar 2011
SOMATOM DEFINITION AS
K103127 · Siemens Medical Solutions USA, Inc. · Mar 2011
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102259 · VATECH Co., Ltd. · Feb 2011
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
K092747 · Philips Medical Systems (Cleveland), Inc. · Oct 2009
GE LIGHTSPEED ACT FP16
K091673 · Ge Medical Systems, Inc. · Jun 2009
BRILLIANCE DUAL ENERGY OPTION
K090462 · Philips Medical Systems (Cleveland), Inc. · Jun 2009