Vatech PaX-i3D Smart

3. Imaging System Overview
19 I
PaX-i3D Smart
English
3.1.3 PaX-i3D Smart Options
Model Item Sensor
SP
PANO+CBCT PANO/CT Xmaru1404CF
SC
PANO+CBCT +CEPH
PANO/CT Xmaru1404CF
CEPH Xmaru2301CF
OS
PANO+CBCT +CEPH
PANO/CT Xmaru1404CF
CEPH 910SGA
OP
PANO+CBCT +CEPH
PANO/CT Xmaru1404CF
CEPH 1210SGA
3.1.5 Standards and Regulations
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Standards
PaX-i3D Smart was designed and developed to comply with the following international
standards and regulations.
IEC/EN 60601-1(3rd), UL 60601-1(1st), IEC/EN 60601-1-3, IEC 60601-2-63
21 CFR 1020.30, 31, 33
NEMA Standard publication PS 3.1-3.18, 2008
This is Class11b equipment and received the CE mark for
regulations compliance in accordance with the revised Medical
Devices Directive 93/42 EEC.
This equipment received the UL certification mark in accordance
with UL 60601-1/CAN/CSA C22.2 No.601.1 regulations.