Skip to content

Arietta 65

by Hitachi Healthcare Americas Corporation 2 variants

510(k) K202422

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK202422 Date4 Nov 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 20 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 Arietta 65 is a portable ultrasound system designed for high-resolution imaging in radiology applications. It provides advanced Doppler and transducer technology to support diagnostic evaluations, particularly in urology and other specialty areas requiring precise real-time visualization.

Supplied as a reusable medical device, the Arietta 65 is intended for use in clinical settings such as hospitals and diagnostic centers. It is cleared by the FDA under 510(k) classification (K202422) and adheres to radiology standards, though specific MRI safety or sterility details are not provided in the data. The system is manufactured by Hitachi Healthcare Americas Corporation and is categorized under product code IYN.

Other devices from Hitachi Healthcare Americas Corporation

See all devices from Hitachi Healthcare Americas Corporation →

Questions

AI-generated answers, 20 Sep 2026

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

  • Is the Arietta 65 designed for single-use or can it be reused in a clinical setting?

    The Arietta 65 is explicitly described as a reusable medical device, intended for use in clinical environments like hospitals and diagnostic centers. Since it is not labeled as single-use, it must be properly cleaned, maintained, and serviced according to manufacturer guidelines to ensure continued safe and effective operation.

  • What types of imaging capabilities does the Arietta 65 offer, and which specialties benefit most from its features?

    The Arietta 65 is engineered for high-resolution imaging, featuring advanced Doppler and transducer technology. It is particularly well-suited for urology and other specialty radiology applications where precise real-time visualization is critical, such as vascular studies or musculoskeletal evaluations.

  • How is the Arietta 65 supplied, and what should buyers consider regarding its portability?

    The Arietta 65 is supplied as a portable ultrasound system, meaning it is designed for mobility within clinical settings like hospitals or diagnostic centers. Its portability allows for flexibility in patient care, enabling imaging to be performed at the bedside or in procedural rooms without requiring a fixed installation.

  • What regulatory pathway was followed for FDA clearance of the Arietta 65, and which advisory committee reviewed it?

    The Arietta 65 was cleared by the FDA under the 510(k) pathway (traditional review, K202422) and was determined to be substantially equivalent to a predicate device. The Radiology (RA) Advisory Committee reviewed the submission, which was filed under product code IYN for radiology applications.