# K093044: Oasis Mri System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Mar 16, 2010 after 167 days
- Product code: LNI (System, Nuclear Magnetic Resonance Spectroscopic)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930265 (1995). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071506: Echelon Spectroscopy Package, Hitachi Medical Systems America, Inc. (2007)

## Most influential descendants
- K192851: OASIS MRI System (2020), 3 descendants of its own
- K202030: OASIS MRI System (2020), 2 descendants of its own
- K211406: OASIS MRI System (2021), 1 descendant of its own
- K240571: OASIS MRI System (2024), 0 descendants of its own

## Recalls of this device
- Jun 18, 2018 · Class II · Z-2479-2018: The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where te

## Indications for use
The Hitachi Oasis MRI with spectroscopy is intended for use as a non-invasive diagnostic device that provides information based on relative concentration of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (Ti), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination. Anatomical Region: Head, body, spine, extremities Nucleus excited: proton Diagnostic uses: Ti, T2, proton density weighted imaging, diffusion weighted imaging, MR angiography, Image processing, spectroscopy, whole body

Source page: https://510kreport.com/device/K093044
Methodology: https://510kreport.com/methodology