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Aloka Arietta 850

by Hitachi Healthcare Americas Corporation 3 variants

510(k) K183456

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK183456 Date28 Jan 2019ClearedStatusActive

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-0190-2022 FDA Class II initiated 14 Oct 2021

    Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

    • Ongoing Z-2308-2021 FDA Class II initiated 30 Jun 2021

    The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.

    • Terminated Z-1282-2021 FDA Class II initiated 1 Mar 2021

    Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYN
FDA applicant
Hitachi Healthcare Americas
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aloka Arietta 850 is an Ultrasonic Pulsed Doppler Imaging System, designed for real-time visualization of internal body structures and blood flow using high-frequency sound waves. It falls under the System, Imaging, Pulsed Doppler, Ultrasonic category (Product Code: IYN) and incorporates advanced Doppler technology to assess vascular and cardiac function.

This device is intended for use in clinical settings such as hospitals, diagnostic imaging centers, and outpatient facilities. Supplied as a reusable medical system, it requires proper maintenance and calibration per manufacturer guidelines. Authorized under 21 CFR 892.1550 and cleared via FDA 510(k) (K183456), it adheres to Class II – Special Controls regulatory standards for pulsed Doppler ultrasound systems.

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