Pax-I3D Smart Options; Standards And Regulations - Vatech PaX-i3D Smart User Manual

3. Imaging System Overview
3.1.3

PaX-i3D Smart Options

Model
SP
PANO+CBCT
SC PANO+CBCT +CEPH
OS PANO+CBCT +CEPH
OP
PANO+CBCT +CEPH
3.1.5

Standards and Regulations

❚
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
Item
PANO/CT
PANO/CT
CEPH
PANO/CT
CEPH
PANO/CT
CEPH
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.
19 I
PaX-i3D Smart
Sensor
Xmaru1404CF
Xmaru1404CF
Xmaru2301CF
Xmaru1404CF
910SGA
Xmaru1404CF
1210SGA