Cleared Traditional

K170909 - Infinix INFX-8000V

K170909 is an FDA 510(k) clearance for Infinix INFX-8000V, manufactured by Toshiba Medical Systems Coroporation. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K170909 · Toshiba Medical Systems Coroporation · Radiology device
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Jun 2017
Decision
80d
Days
Class 2
Risk

K170909 is an FDA 510(k) clearance for the Infinix INFX-8000V, V6.40. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Toshiba Medical Systems Coroporation (Otawara-Shi, JP). The FDA issued a Cleared decision on June 16, 2017 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toshiba Medical Systems Coroporation devices

FDA 510(k) Submission Details - K170909

510(k) Number K170909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2017
Decision Date June 16, 2017
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
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.

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All 242
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