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FDA 510(k)

OASIS MRI SYSTEM

K-Number: K093044 · 2010-03-16

ApplicantHitachi Medical Systems America, Inc.
Decision Date2010-03-16
Product CodeLNI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OASIS MRI SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2010-03-16 under 510(k) number K093044. The device is classified under product code LNI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OASIS MRI SYSTEM?

OASIS MRI SYSTEM is a medical device that received FDA 510(k) clearance on 2010-03-16. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K093044.

When did OASIS MRI SYSTEM receive FDA 510(k) clearance?

OASIS MRI SYSTEM received FDA 510(k) clearance on 2010-03-16, under 510(k) number K093044.

Who is the listed applicant for OASIS MRI SYSTEM?

The FDA 510(k) record lists Hitachi Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OASIS MRI SYSTEM?

The FDA product code for OASIS MRI SYSTEM is LNI.

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Other records listing Hitachi Medical Systems America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LNI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071506ECHELON SPECTROSCOPY PACKAGEHitachi Medical Systems America, Inc.K011604PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRIGe Medical Systems, Inc.K010129EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3Toshiba America Medical Systems, In.CK003575MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEMGE Medical SystemsK991568MR SPECTROSCOPY PACKAGEPhilips Medical Systems (Cleveland), Inc.K984167SAGE 7GE Medical Systems

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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