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Hitachi Healthcare Americas Corporation

United StatesFDA applicant, unverified

Devices
17
FDA recalls
41 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Hitachi Healthcare Americas Corporation makes

The company manufactures ultrasound imaging systems, including portable and high-end models like the ARIETTA 750 and ARIETTA 850, designed for diagnostic and procedural applications. It also produces whole-body X-ray CT systems such as the Supria True64, MRI systems including the ECHELON OVAL V6.0A and OASIS models, and optical topography devices like the ETG-4100 for neuroimaging. Additional offerings include the SCENARIA View, a specialized imaging system for soft tissue evaluation.

These devices are classified under Class II in the US and are listed via the FDA’s 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue17

Newest first, rows 1-17 of 17

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  • Supria True64 Ref K171738

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Arietta 750 Ref K191233 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • ECHELON OVAL V6.0A MRI System Ref K172110

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • OASIS MRI System Ref K192851

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Aloka Arietta 850 Ref K173739 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • OASIS MRI System Ref K211406

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Arietta 50 Ref K190248

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Supria True64 Whole-Body X-Ray CT System Ref K183291 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Aloka Arietta 850 Ref K183456 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Optical Topography System ETG-4100 Ref K172492

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • SCENARIA View Ref K190841

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Arietta 65 Ref K181376 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • SCENARIA View Ref K200498

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Arietta 65 Ref K202422

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • OASIS MRI System Ref K202030

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Low Dose CT Lung Cancer Screening Option Ref K180901

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Aloka Arietta 850 Ref K171708 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-17 of 17

FDA recalls4

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 4 recalls initiated by Hitachi Healthcare Americas Corporation, the earliest on 2021-06-30 and the most recent on 2021-07-29. By recorded status: 1 ongoing and 3 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 4
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2021

    • 29 Jul 2021 Z-2337-2021 Class II Terminated There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437. Distribution: Worldwide distribution - US Nationwide and the countries of Mexico and Brazil. Submission number: K083533
    • 29 Jul 2021 Z-2338-2021 Class II Terminated There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437. Distribution: Worldwide distribution - US Nationwide and the countries of Mexico and Brazil. Submission number: K172110
    • 29 Jul 2021 Z-2339-2021 Class II Terminated There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437. Distribution: Worldwide distribution - US Nationwide and the countries of Mexico and Brazil. Submission number: K202030
    • 30 Jun 2021 Z-2308-2021 Class II Ongoing 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. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Submission numbers: K183456, K173739

Frequently asked questions

How many devices does Hitachi Healthcare Americas Corporation have in the registry?

The registry currently lists 17 devices for Hitachi Healthcare Americas Corporation. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hitachi Healthcare Americas Corporation's devices?

Among its 17 most recently registered devices, Hitachi Healthcare Americas Corporation has devices listed in FDA 510(k) (17 devices).

What risk classes do Hitachi Healthcare Americas Corporation's devices fall under?

Among its 17 most recently registered devices, the classes recorded for Hitachi Healthcare Americas Corporation's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Hitachi Healthcare Americas Corporation?

FDA recall records list 4 recalls initiated by Hitachi Healthcare Americas Corporation, the most recent initiated on 29 Jul 2021. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Hitachi Healthcare Americas Corporation in the registry?

The most recently registered devices listed for Hitachi Healthcare Americas Corporation include Supria True64, ARIETTA 750, ECHELON OVAL V6.0A MRI System and OASIS MRI System.

Generated automatically from registry data and not verified by a human reviewer.