Cleared Traditional

K140639 - PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM

K140639 is an FDA 510(k) clearance for PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Hitachi Aloka Medical, Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K140639 · Hitachi Aloka Medical, Ltd. · Radiology device
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Apr 2014
Decision
35d
Days
Class 2
Risk

K140639 is an FDA 510(k) clearance for the PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM. 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 Hitachi Aloka Medical, Ltd. (Wallingford, US). The FDA issued a Cleared decision on April 16, 2014 after a review of 35 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 Hitachi Aloka Medical, Ltd. devices

FDA 510(k) Submission Details - K140639

510(k) Number K140639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2014
Decision Date April 16, 2014
Days to Decision 35 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
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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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