Rcim Label; Udi Label - GE Optima XR646 Operator's Manual

RCIM Label

Figure 2-13 RCIM Label
WARNING This X-Ray unit may be dangerous to the patient and operator, unless
safe exposure factors, operating instructions and maintenance sched-
ules are observed. To be used by authorized personnel only.

UDI Label

Every Optima XR646 system has an unique marking for identification. The Unique Device
Identification (UDI) marking appears on the product label which is located on system cabinet.
UDI: Unique Device Identifier - A UDI is an unique numeric or alphanumeric identification code
assigned to medical devices by the manufacturer of the device. An unique device identifica-
tion marking is applied to a Product Model that is designated as a medical device as per FDA
UDI regulation.
5495975-1EN Rev.9
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Chapter 2: Safety and Regulatory
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