K121019

Substantially Equivalent

OPTIMA NM/CT 640

Applicant: GE Healthcare
Product 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.