Cleared Traditional

FUKUDA DENSHI MODEL FF SONIC UF-750XT (K033209) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033209 · Fukuda Denshi USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
28d
Days
Class 2
Risk

K033209 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL FF SONIC UF-750XT. 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 October 31, 2003 after a review of 28 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 K033209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2003
Decision Date October 31, 2003
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 535
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K033209.
GE VIVID 7 BT04
K041552 · General Electric Co. · Jul 2004
SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
K041319 · Siemens Medical Solutions USA, Inc. · Jun 2004
SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS
K040060 · Siemens Medical Solutions USA, Inc. · Jan 2004
GE MARLIN ULTRASOUND
K033139 · General Electric Co. · Oct 2003
GE LOGIQ BOOK
K032477 · General Electric Co. · Oct 2003
GE LOGIQ 5 PRO OR EXPERT
K032974 · General Electric Co. · Oct 2003