OASIS MRI SYSTEM— 510(k) K093044

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..

Clearance details

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

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