Gendex 765DC User Manual

765DC
5
Authorized Representative:
GENDEX Dental Systems s.r.l. GENDEX Dental Systems
Via A, Manzoni 44 901 West Oakton Street
20095 Cusano Milanino - Mi Des Plaines, IL 60018-1884
Tel: +39.02.61800.81 Tel: (847)640-4800
Fax: +39.02.61800.809 Fax (847)640-4891
EC Declaration of Conformity
A. Name/Description of product:
Gendex 765DC Intraoral X-Ray System
REF: Model 110-0154G1,G2,G3
Class: IIb
B. Reference Standards under which conformity is declared:
IEC60601-1:1988 +A1:1991 +A2:1995
IEC60601-1-1:2000
IEC60601-1-2:2001 IEC60601-2-28:1993 IEC60522:2003
IEC60601-1-3:1994 IEC60601-2-32:1994 IEC60878:2003
IEC60601-1-4:1996 IEC60336:2005 EN 980:1997
IEC60601-2-7:1998 IEC60417:1973 ISO14971:2000
C. GENDEX Dental Systems, Inc. declares that the products described
herein meet all the applicable Essential Requirements of the EC
Medical Device Directive 93/42/EEC in Annex I. For Class IIb products
described herein, the product is manufactured, inspected, tested, and
released in accordance with the approved quality assurance system
established in accordance with ISO 9001, EN 46001 and Annex II of the
EC Medical Device Directive under the supervision of the British
Standards Institution, a Notified Body carrying the Notified Body
No. 0086.
John R. Miller
Director of QA/RA
GENDEX Dental Systems

Gendex 765DC Specifications

General

Brand	Gendex
Model	765DC
Category	Medical Equipment
Language	English