OASIS MRI SYSTEM— 510(k) K093044

Name: FDA 510(k) clearance K093044
Creator: U.S. Food and Drug Administration
Published: 2010-03-16

Substantially Equivalent

Hitachi Medical Systems America, Inc.

FDA 510(k) clearance K093044 for OASIS MRI SYSTEM, Substantially Equivalent on 2010-03-16. Applicant: Hitachi Medical Systems America, Inc.. Device class: 2.

Clearance details

Applicant: Hitachi Medical Systems America, Inc.
Product code: Code LNI
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2009-09-30
Decision date: 2010-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K093044

K-number listed on FDA's recall record

Z-2479-2018 — Hitachi Oasis MRI system Product Usage: Hitachi 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 Oasis system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems 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.Class II·Terminated·Hitachi Medical Systems America Inc·20180618

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093044.

Data sourced from openFDA. This site is unofficial and independent of the FDA.