# K072279: Magnetic Resonance Diagnostic Device

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Sep 21, 2007 after 36 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K955249 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052172: HHF1 Magnetic Resonance Imaging System, Hitachi Medical Systems America, Inc. (2005) Summary page 1.

## Recalls of this device
- Jan 6, 2017 · Class II · Z-1096-2017: The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
- Apr 25, 2014 · Class II · Z-2366-2015: The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
- Jan 31, 2013 · Class II · Z-1559-2013: Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error can occur randomly. T
- Jun 15, 2012 · Class II · Z-2254-2012: Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from anoth
- Sep 1, 2009 · Not classified · Z-1534-2010: The device has a software error that could potentially lead to a misdiagnosis.

## Indications for use
The OASIS 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.

Source page: https://510kreport.com/device/K072279
Methodology: https://510kreport.com/methodology