GEM OPTION FOR 1.5 MRI SYSTEMS— 510(k) K103335

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K103335 for GEM OPTION FOR 1.5 MRI SYSTEMS, Substantially Equivalent on 2011-03-07. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code MOS
Advisory panel: Radiology
Date received: 2010-11-15
Decision date: 2011-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aurora, OH, US

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