Cleared Traditional

K142736 - XIDF-AWS801

K142736 is the FDA 510(k) clearance for XIDF-AWS801 by Toshibamedical Systems Corporation. It is a Class 2 Radiology device (product code OWB) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K142736 · Toshibamedical Systems Corporation · Radiology device
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Mar 2015
Decision
169d
Days
Class 2
Risk

K142736 is an FDA 510(k) clearance for the XIDF-AWS801, Angio Workstation, v5.31. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Toshibamedical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on March 11, 2015 after a review of 169 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 K142736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2014
Decision Date March 11, 2015
Days to Decision 169 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
62d slower than avg
Panel avg: 107d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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
Paul Biggins

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.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 240
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K142736.
O-Arm O2 Imaging System
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SyncVision System
K151904 · Volcano Corporation · Jul 2015
XIDF-AWS801, Angio Workstation, V6.10
K150967 · Toshibamedical Systems Corporation · Jun 2015
EmboGuide
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Ultimax-i
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INFX-8000V with Wireless Footswitch
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