Cleared Traditional

K082656 - MODEL FF SONIC US-750 XT DIAGNOSTIC ULT...

K082656 is the FDA 510(k) clearance for MODEL FF SONIC US-750 XT DIAGNOSTIC ULT... by Fukuda Denshi USA, Inc.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K082656 · Fukuda Denshi USA, Inc. · Radiology device
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Sep 2008
Decision
18d
Days
Class 2
Risk

K082656 is an FDA 510(k) clearance for the MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Redmond, US). The FDA issued a Cleared decision on September 30, 2008 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Fukuda Denshi USA, Inc. devices

Submission Details

510(k) Number K082656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2008
Decision Date September 30, 2008
Days to Decision 18 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 107d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

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