207723 rev 7
Gendex Dental Systems 97
9 Technical data
9.1 Technical specifications
Manufactured for: Gendex Dental Systems
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.
GXDP-700 is in conformity with the provisions of Council
Directive 93/42/EEC as amended by the Directive 2007/
47/EC concerning medical devices.
Performance Standards and European Union Directive
93/42/EEC (Medical Devices Directive).
Product name GXDP-700
Model: GXDP-700
Product type: Digital dental imaging system with panoramic
cephalometric and Cone Beam 3D imaging programs.
Approved: Laihonen Tuuli 2016-12-02 16:41
Reviewed: Nieminen Timo Antero 2016-12-02 15:31
Approved
See PDM system to determine the status of this document. Printed out: 2017-03-22 10:54:38
D507729, 7
Copyright © 2016 by PaloDEx Group Oy. All rights reserved.
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