Cleared Traditional

K133535 - INFX-8000V, V5.30

K133535 is an FDA 510(k) clearance for INFX-8000V, manufactured by Toshibamedical Systems Corporation. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K133535 · Toshibamedical Systems Corporation · Radiology device
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Jul 2014
Decision
247d
Days
Class 2
Risk

K133535 is an FDA 510(k) clearance for the INFX-8000V, V5.30. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Toshibamedical Systems Corporation (Tustin, US). The FDA issued a Cleared decision on July 23, 2014 after a review of 247 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

FDA 510(k) Submission Details - K133535

510(k) Number K133535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2013
Decision Date July 23, 2014
Days to Decision 247 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
140d slower than avg
Panel avg: 107d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

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 Peers - OWB Interventional Fluoroscopic X-ray System

All 298
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