Magnetic Resonance Diagnostic Device

• • Terminated Z-1096-2017 FDA Class II ·initiated 6 Jan 2017

  The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.

• • Terminated Z-2366-2015 FDA Class II ·initiated 25 Apr 2014 ·on shared 510(k) K072279

  The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.

• • Terminated Z-1559-2013 FDA Class II ·initiated 31 Jan 2013

  Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error can occur randomly. The error causes an image in the processed dataset to have the same unique identifier (UID) as in the scanning dataset. The processed image is stored in the place of the original image, which is lost.

• • Terminated Z-2254-2012 FDA Class II ·initiated 15 Jun 2012

  Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from another view (i.e. axial to coronal, coronal to sagittal, etc.). The error causes the first image in the dataset to have a right/left reversed orientation. The software error can occur randomly when execu

• • Terminated Z-1534-2010 FDA Unclassified (pre-2012) ·initiated 1 Sep 2009 ·on shared 510(k) K072279

  The device has a software error that could potentially lead to a misdiagnosis.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K072279 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• Magnetic Resonance Diagnostic Device, Model Mrp-5000

  Class II

  FDA 510(k) K984272 Active Cleared 11 Dec 1998

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• ECG Monitor Model Ds-3130/3140

  Class II

  FDA 510(k) K961174 Active Cleared 21 Jun 1996

• SUPRIA w/guideShot Option

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  FDA 510(k) K161748 Active Cleared 17 Aug 2016

See all devices from Hitachi Medical Systems America, Inc. →

• What is the primary use of this MRI system?

  This Nuclear Magnetic Resonance Diagnostic Device is designed to create detailed images of internal body structures using magnetic resonance technology. It enables physicians to assess anatomical and pathological features without exposing patients to ionizing radiation, making it ideal for diagnosing a wide range of physiological and clinical conditions in radiology departments and imaging centers.

• Is this device single-use or reusable?

  This MRI system is intended for reusable use. It requires proper installation, calibration, and maintenance as outlined by the manufacturer to ensure consistent performance and safety. Reusability is standard for high-end diagnostic imaging equipment like this, as it allows for ongoing clinical use while adhering to strict MRI safety protocols.

• What safety precautions must be followed when using this device?

  The system must be handled in compliance with MRI safety protocols, including proper shielding and electromagnetic interference precautions. Since it operates using strong magnetic fields, all personnel and equipment must be kept at a safe distance to avoid hazards such as accidental injury or interference with other devices. Manufacturer guidelines must be strictly followed during installation, operation, and maintenance.

• How is this device regulated and approved?

  This device is authorized under FDA 510(k) clearance with the reference number K072279. It falls under FDA Device Class 2 and is regulated under 21 CFR 892.1000. The clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for diagnostic imaging.

• What types of images can this MRI system produce?

  The system generates transverse and other plane images, allowing for comprehensive visualization of internal structures. These images assist physicians in evaluating anatomical details and identifying pathological features, such as tumors, organ abnormalities, or soft tissue injuries, without the use of ionizing radiation.