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OASIS MRI System

by Hitachi Healthcare Americas Corporation 3 variants

510(k) K192851

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 NumberK192851 Date21 Feb 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  • Withdrawn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
LNH
FDA applicant
Hitachi Healthcare Americas
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 OASIS MRI System is a nuclear magnetic resonance imaging system designed for diagnostic imaging. It features a vertical field magnet and advanced RF technology to provide high-performance imaging capabilities.

The system is manufactured by Hitachi Healthcare Americas Corporation and was cleared by the FDA through a 510(k) process with product code LNH. It is a Class 2 device regulated under 892.1000 and is intended for use in radiology settings.

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Questions

AI-generated answers, 25 Sep 2026

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

  • What is the OASIS MRI System used for?

    The OASIS MRI System is a nuclear magnetic resonance imaging device designed for diagnostic imaging in radiology settings. It features a vertical field magnet and advanced RF technology to provide high-performance imaging capabilities.

  • How is the OASIS MRI System supplied and what are its sterility requirements?

    The device is supplied as a complete MRI system unit. The device data does not specify sterility requirements, as it is a diagnostic imaging system rather than a single-use medical device that would require sterility.

  • Is the OASIS MRI System reusable or single-use?

    The OASIS MRI System is a diagnostic imaging system designed for repeated use in clinical settings. It is not a single-use device and is intended for long-term operation in radiology departments.

  • What regulatory approvals does the OASIS MRI System have?

    The OASIS MRI System was cleared by the FDA through a 510(k) process with product code LNH. It is classified as a Class 2 device regulated under 892.1000 and received a substantially equivalent decision in February 2020.