Hitachi Stratis MRH-1500 Magnetic Resonance Diagnostic Device Version 6 Operating System Software
by Hitachi Medical Systems America, Inc.
510(k) K961969
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961969 | Date5 Sep 1996 | 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- Withdrawn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
- Full name
- Hitachi Stratis, Mrh-1500 Magnetic Resonance Diagnostic Devices Version 6 Operating System Software
- 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
The Hitachi Stratis MRH-1500 is a magnetic resonance imaging (MRI) system operating system software designed for diagnostic imaging. It processes radiofrequency (RF) signals from hydrogen nuclei within a magnetic field to generate detailed anatomical images, utilizing magnetic field gradients for spatial localization. This software version enhances imaging capabilities through updated algorithms and post-processing functions, supporting clinical diagnostic workflows. The device falls under the category of MRI diagnostic equipment, enabling non-invasive visualization of internal body structures for medical evaluation.
This operating system software is supplied as a digital update for the Hitachi Stratis MRH-1500 MRI system and is intended for use in clinical radiology settings. It is not classified as a single-use or reusable consumable but rather as a software upgrade for existing MRI hardware. The device operates within standard MRI safety protocols, including compliance with electromagnetic interference guidelines. Authorized for use in the United States under FDA 510(k) clearance (K961969), it adheres to regulatory standards for diagnostic imaging systems, ensuring reliability and performance in medical diagnostics.
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Questions
AI-generated answers, 1 Oct 2026
What is the Hitachi Stratis MRH-1500 Version 6 software designed for?
The Hitachi Stratis MRH-1500 Version 6 operating system software is designed to upgrade existing Hitachi Stratis MRH-1500 MRI systems. It enhances diagnostic imaging by improving radiofrequency signal processing and incorporating updated algorithms for better anatomical visualization. This software is specifically tailored to support clinical radiology workflows, ensuring more precise and detailed MRI scans for internal body structures.
How is the Hitachi Stratis MRH-1500 Version 6 software supplied?
This software is supplied as a digital update, meaning it is delivered electronically rather than as physical hardware or consumables. It is intended to be installed on compatible Hitachi Stratis MRH-1500 MRI systems to provide the latest imaging capabilities. The update ensures the MRI system operates with the latest enhancements without requiring additional physical components.
Is the Hitachi Stratis MRH-1500 Version 6 software single-use or reusable?
The software is not a single-use item; it is designed as a reusable upgrade for the Hitachi Stratis MRH-1500 MRI system. Once installed, it remains functional on the MRI hardware, allowing for continued use of its enhanced imaging features. This makes it a cost-effective solution for maintaining and improving diagnostic performance over time.
What regulatory approval does the Hitachi Stratis MRH-1500 Version 6 software hold?
The software holds FDA 510(k) clearance under the reference number K961969, indicating it has been deemed substantially equivalent to a legally marketed device. This approval ensures it meets regulatory standards for safety and effectiveness in clinical diagnostic imaging settings. The clearance is specific to the United States and confirms compliance with electromagnetic interference guidelines.
Does the Hitachi Stratis MRH-1500 Version 6 software require special storage or handling?
As a digital update, the software does not require physical storage like consumables or hardware. However, it must be installed on a compatible MRI system with proper IT infrastructure to ensure compatibility and functionality. The installation process should follow manufacturer guidelines to maintain data integrity and system performance, and it is important to ensure the MRI system’s operating environment adheres to standard MRI safety protocols.