206718 rev 9
SOREDEX 95
9 Technical data
9.1 Technical specifications
Manufacturer SOREDEX, PaloDEx Group Oy, Nahkelantie 160 2064
FIN-04300 Tuusula, FINLAND
Quality system In accordance with ISO13485 and ISO9001 standard
Environmental
management system
In accordance with ISO14001 standard
Conformity to standards:
IEC 60601-1
IEC 60601-1-1
IEC 60601-1-4
IEC 60601-2-7
IEC 60601-2-28
IEC 60601-2-32
IEC 60601-2-63
IEC 60601-1-2
IEC 60601-1-3
UL 60601-1
CAN/CSA –C22.2 No. 601-1-M90
This product complies with DHHS 21 CFR Chapter I,
Subchapter J at the date of manufacture.
Product name CRANEX 3D
Model: CRANEX 3D
Product type: Digital dental imaging system with panoramic,
cephalometric and Cone Beam 3D imaging programs.
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