Cleared Traditional

K170177 - Aquilion ONE (TSX-305A/3) V8.3 with FIR...

K170177 is the FDA 510(k) clearance for Aquilion ONE (TSX-305A/3) V8.3 with FIR... by Toshibamedical Systems Corporation. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K170177 · Toshibamedical Systems Corporation · Radiology device
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Jun 2017
Decision
162d
Days
Class 2
Risk

K170177 is an FDA 510(k) clearance for the Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Toshibamedical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on June 30, 2017 after a review of 162 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 Toshibamedical Systems Corporation devices

Submission Details

510(k) Number K170177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2017
Decision Date June 30, 2017
Days to Decision 162 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
55d slower than avg
Panel avg: 107d · This submission: 162d
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 Consultant

Toshiba America Medical Systems, In.C
Orlando Tadeo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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