Cleared Traditional

K171708 - ALOKA ARIETTA 850

K171708 is the FDA 510(k) clearance for ALOKA ARIETTA 850 by Hitachi Healthcare Americas Corporation. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K171708 · Hitachi Healthcare Americas Corporation · Radiology device
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Oct 2017
Decision
145d
Days
Class 2
Risk

K171708 is an FDA 510(k) clearance for the ALOKA ARIETTA 850. 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 Healthcare Americas Corporation (Twinsburg, US). The FDA issued a Cleared decision on October 31, 2017 after a review of 145 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hitachi Healthcare Americas Corporation devices

Submission Details

510(k) Number K171708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2017
Decision Date October 31, 2017
Days to Decision 145 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
38d slower than avg
Panel avg: 107d · This submission: 145d
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 787
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K171708.
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