OPTIMA XR120— 510(k) K111304

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K111304 for OPTIMA XR120, Substantially Equivalent on 2011-07-19. Applicant: Ge Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code IXL
Device class: Class 2
Regulation: 21 CFR 892.1670
Advisory panel: Radiology
Date received: 2011-05-09
Decision date: 2011-07-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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