Cleared Traditional

K123828 - PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM

K123828 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 37-day FDA review.

K123828 · Hitachi Aloka Medical, Ltd. · Radiology device
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Jan 2013
Decision
37d
Days
Class 2
Risk

K123828 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 January 18, 2013 after a review of 37 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 - K123828

510(k) Number K123828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2012
Decision Date January 18, 2013
Days to Decision 37 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
70d faster than avg
Panel avg: 107d · This submission: 37d
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

All 923
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