Cleared Traditional

ARIETTA 750 (K191233) - FDA 510(k) Clearance

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

K191233 · Hitachi Healthcare Americas · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
93d
Days
Class 2
Risk

K191233 is an FDA 510(k) clearance for the ARIETTA 750. 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 (Twinsburg, US). The FDA issued a Cleared decision on August 9, 2019 after a review of 93 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 devices

Submission Details

510(k) Number K191233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2019
Decision Date August 09, 2019
Days to Decision 93 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
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 631
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K191233.
Clarius Ultrasound Scanner
K192107 · Clarius Mobile Health Corp. · Aug 2019
Voluson E6, Voluson E8, Voluson E10
K192159 · Ge Healthcare · Aug 2019
ACUSON P200 Diagnostic Ultrasound System
K191922 · Siemens Medical Solutions USA, Inc. · Aug 2019
Versana Balance
K191792 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Aug 2019
Versana Active
K191798 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Aug 2019
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
K191467 · Canon Medical Systems Corporation · Jul 2019