Version 4 Operating System Software
by Hitachi Medical Systems America, Inc.
510(k) K971279
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971279 | Date3 Jul 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LNH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a System, Nuclear Magnetic Resonance Imaging (per FDA classification), designed as software for MRI systems. It processes RF emissions from hydrogen nuclei relaxation within a magnetic field to generate diagnostic images. The software enables spatial localization via magnetic field gradients (x, y, z axes) and reconstructs images through 3D matrix processing, forming the core computational framework for MRI operation.
The Version 4 Operating System Software is supplied as a digital update for Hitachi AIRIS and MRP-7000 MRI systems, intended for use in radiology settings. It is not classified as single-use or reusable but rather as a software upgrade installed on existing MRI hardware. The device is not sterile and requires no special storage conditions beyond standard IT infrastructure. It holds an FDA 510(k) clearance (K971279) under the Radiology advisory committee, with regulatory classification as Class II.
Other devices from Hitachi Medical Systems America, Inc.
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Questions
AI-generated answers, 1 Oct 2026
What is the Hitachi MRI Version 4 Operating System Software used for?
This software serves as the core computational framework for Hitachi AIRIS and MRP-7000 MRI systems, processing RF emissions from hydrogen nuclei relaxation within a magnetic field. It enables spatial localization across the x, y, and z axes using magnetic field gradients and reconstructs diagnostic images through advanced 3D matrix processing. It is designed to improve image quality and functionality for radiology settings.
How is the Version 4 Operating System Software supplied and installed?
The software is supplied as a digital update, meaning it is distributed electronically rather than as a physical product. It is installed directly onto existing Hitachi AIRIS and MRP-7000 MRI hardware, replacing or upgrading the current operating system. No additional hardware or sterile packaging is required—only standard IT infrastructure for installation.
Is the Version 4 Operating System Software sterile or single-use?
No, the software is neither sterile nor single-use. It is a reusable digital upgrade intended for repeated installation on compatible MRI systems. Since it is not a physical consumable or disposable item, sterility is not applicable, and it can be reinstalled as needed for system maintenance or upgrades.
What MRI systems is this software compatible with?
The Version 4 Operating System Software is specifically designed for Hitachi AIRIS and MRP-7000 MRI systems. The listed FEI numbers in the regulatory data confirm compatibility with multiple models within these series, ensuring it can be installed on a range of compatible hardware for consistent performance.
Are there any special storage requirements for this software?
No special storage conditions are required beyond standard IT infrastructure. Since the software is digital, it must be stored securely on a compatible server or installation medium (e.g., USB drive or network storage) that meets the MRI system manufacturer’s technical specifications. Always follow Hitachi’s guidelines for software storage and backup to prevent data loss.