Cleared Traditional

K132222 - AQUILION ONE VISION, V6.0

K132222 is an FDA 510(k) clearance for AQUILION ONE VISION, manufactured by Toshibamedical Systems Corporation. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K132222 · Toshibamedical Systems Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
113d
Days
Class 2
Risk

K132222 is an FDA 510(k) clearance for the AQUILION ONE VISION, V6.0. 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 7, 2013 after a review of 113 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. 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 Toshibamedical Systems Corporation devices

FDA 510(k) Submission Details - K132222

510(k) Number K132222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2013
Decision Date November 07, 2013
Days to Decision 113 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
6d slower than avg
Panel avg: 107d · This submission: 113d
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 727
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K132222.
CT PULMONARY ANALYSIS
K130552 · Qi Imaging, LLC · Jan 2014
SOMATOM DEFINITION AS OPEN
K130901 · Siemens Medical Systems, Inc. · Jan 2014
MYOPERFUSION
K132523 · Toshibamedical Systems Corporation · Dec 2013
AIRO CT SYSTEM
K131431 · Mobius Imaging, LLC · Sep 2013
BRILLIANCE ICT
K131773 · Philips Healthcare (Cleveland) · Sep 2013
OPTIMA CT660
K131576 · Ge Medical Systems, LLC · Aug 2013