Magnetic Resonance Diagnostic Device
by Hitachi Medical Systems America, Inc. 4 variants
510(k) K942560
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK942560 | Date9 Sep 1994 | 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- Withdrawn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 Nuclear Magnetic Resonance Imaging System, classified under the FDA’s product code LNH. It generates detailed images of the human body’s internal structures by exploiting the magnetic properties of hydrogen atoms in tissues, producing transverse and other plane views without ionizing radiation. The system is designed for radiologic diagnostic purposes, enabling physicians to assess anatomical and physiological conditions non-invasively.
The device is supplied as a reusable, hospital-based system, intended for use in radiology departments equipped for MRI. It operates under regulatory oversight as a Class II medical device under 21 CFR 892.1000, with multiple FDA 510(k) clearances (e.g., K942560, K953918) reflecting its substantial equivalence to predicate devices. No sterility or single-use specifications are noted; its operation requires compliance with MRI safety protocols, including shielding and electromagnetic interference controls. Authorized field installations are tracked via registration numbers (e.g., 3008156140).
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Questions
AI-generated answers, 1 Oct 2026
What is the primary use of the Hitachi MRI System?
The Hitachi MRI System is designed for radiologic diagnostic purposes, enabling physicians to create detailed images of internal body structures without using ionizing radiation. It exploits the magnetic properties of hydrogen atoms in tissues to produce transverse and other plane views, helping assess anatomical and physiological conditions non-invasively. This is particularly useful for evaluating soft tissues, organs, and musculoskeletal systems.
How is the Hitachi MRI System supplied and where is it intended for use?
The Hitachi MRI System is supplied as a reusable, hospital-based device. It is intended for use in radiology departments equipped to handle MRI technology. Its installation and operation require compliance with MRI safety protocols, including electromagnetic interference controls and shielding, to ensure safe and effective imaging.
Is the Hitachi MRI System single-use or reusable?
The Hitachi MRI System is a reusable device. It is not intended for single-use applications and is designed for long-term use in clinical settings, provided it adheres to manufacturer guidelines and maintenance protocols to ensure reliability and safety.
What regulatory approvals does the Hitachi MRI System hold?
The Hitachi MRI System holds FDA 510(k) clearance, indicating it has been deemed substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device under 21 CFR 892.1000, reflecting its regulatory oversight and compliance requirements for safety and performance.
How are installations of the Hitachi MRI System tracked?
Authorized field installations of the Hitachi MRI System are tracked via registration numbers, such as 3008156140. These numbers help ensure proper documentation, maintenance, and compliance with regulatory requirements for MRI systems in clinical environments.