OPTIMA NM/CT 640— 510(k) K121019

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K121019 for OPTIMA NM/CT 640, Substantially Equivalent on 2012-04-19. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code KPS
Advisory panel: Radiology
Date received: 2012-04-04
Decision date: 2012-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Hacarmel, IL

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