# K984272: Magnetic Resonance Diagnostic Device, Model MRP-5000

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Dec 11, 1998 after 11 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hitachi MRP-5000 with Neck/Joint Coil: named in the summary without a submission number
- (no number) Hitachi MRP-7000/AIRIS with QD C-Spine Coil: named in the summary without a submission number

## Indications for use
The QD C-Spine Coil provides imaging of the cervical spine anatomy; dependent upon patient anatomy, the coil sensitivity may additionally image upper thoracic and lower cranial structures. The MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. @® Anatomical Region: Head, Body, Spine, Extremities ® Nucleus excited: Proton ® Diagnostic uses: 2D T1- / T2-weighted imaging T1, T2, proton density measurements MR Angiography image processing @® Imaging capabilities: 2D Spin Echo (SE); also with rephase 2D Gradient Field Echo (GE); also with rephase (2D GR) 2D Inversion Recovery (IR) 2D Fast Spin Echo (FSE) 2D Dual Slice acquisition (SEDS) 3D Spin Echo (SE) 3D Gradient Field Echo (GE); also with rephasing 3D Steady-state Acquisition with Rephased Gradient Echo (SG) MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition) RF Coil Uniformity Adaptive Image post-processing ACR/NEMA/DICOM 3 compliant

Source page: https://510kreport.com/device/K984272
Methodology: https://510kreport.com/methodology