Mrp-5000 and Mrp-7000 Multiplanar Reconstruction
by Hitachi Medical Systems America, Inc.
510(k) K911642
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911642 | Date30 May 1991 | 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- Withdrawn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
The MRP-5000 and MRP-7000 are Nuclear Magnetic Resonance Imaging Systems designed for multoplanar reconstruction. These devices generate detailed cross-sectional images of the body in multiple planes—axial, sagittal, and coronal—enabling comprehensive diagnostic evaluation of anatomical structures. Their primary function is to enhance visualization for radiologic assessment, particularly in musculoskeletal, cardiac, and neurological applications.
These systems are intended for use in MRI-compatible clinical settings, where they operate under controlled conditions to ensure image accuracy and patient safety. Supplied as reusable medical devices, they require proper calibration, maintenance, and adherence to FDA 510(k) clearance (K911642) and regulatory standards (e.g., 21 CFR 892.1000). The MRP-5000 and MRP-7000 are classified as Class II devices under the FDA’s regulatory framework, with no specific single-use or sterility requirements stated in the data. Their operation adheres to MRI safety protocols, and they are not intended for use outside approved imaging environments.
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Questions
AI-generated answers, 1 Oct 2026
What are the MRP-5000 and MRP-7000 designed for?
These devices are Nuclear Magnetic Resonance Imaging Systems specifically engineered for multoplanar reconstruction. They generate detailed cross-sectional images in axial, sagittal, and coronal planes, improving diagnostic evaluation of anatomical structures. This capability is particularly useful for assessing musculoskeletal, cardiac, and neurological conditions, where precise visualization is critical.
How are the MRP-5000 and MRP-7000 supplied and maintained?
The MRP-5000 and MRP-7000 are reusable medical devices. They require proper calibration and maintenance to ensure accurate imaging and patient safety. Since they operate under controlled MRI-compatible conditions, adherence to manufacturer guidelines and regulatory standards (such as FDA 510(k) clearance K911642) is essential. Regular servicing and compliance with MRI safety protocols are also necessary to sustain optimal performance.
Are there any specific sterility or single-use requirements for these systems?
The MRP-5000 and MRP-7000 are classified as reusable medical devices and do not have specific single-use or sterility requirements stated in the available data. However, they must be maintained in a clean and sterile environment when accessed for patient use, following standard MRI facility protocols to prevent contamination and ensure patient safety.
What regulatory pathway does the MRP-5000/7000 follow?
The MRP-5000 and MRP-7000 are FDA-cleared under the 510(k) pathway with clearance number K911642. They are classified as Class II devices under the FDA’s regulatory framework. The devices were reviewed by the Radiology Advisory Committee and are intended for use in MRI-compatible clinical settings, adhering to regulatory standards such as 21 CFR 892.1000.
Where can these systems be used, and what safety protocols apply?
The MRP-5000 and MRP-7000 are designed exclusively for use in MRI-compatible clinical environments. Their operation adheres to strict MRI safety protocols to ensure patient safety and image accuracy. These systems are not intended for use outside approved imaging facilities, where controlled conditions are necessary to mitigate risks associated with magnetic fields and radiofrequency emissions.