General Information Preva
3
Compliance with Applicable Standards
Radiation
Protection
The certified components of the Preva Dental X-Ray System comply with
Radiation Performance Standards 21 CFR, Subchapter J, at the time of
manufacture.
The certified components of the Preva Dental X-Ray System comply with IEC
60601-1-3 Radiation protection/x-ray equipment.
UL 2601-1 File
Number:
E181750
Classified by Underwriters Laboratories Inc. with respect to electrical shock, fire
and mechanical hazards only in accordance with UL 2601-1, and CAN/CSA
C22.2 NO, 601.1-M90, and to the following particular standards, IEC60601-2-7,
IEC60601-2-28.
EMI/EMC
IEC60601-1-2
Certified Components
Component
Tubehead
Control Unit
Cone 8 in.
Cone 12 in.
Cone 8 in. Rectangular
Cone 12 in. Rectangular
Cone 59 mm
Cone 60 mm
Reference Number
30-A1027
30-A0010
30-A2016
30-A2033
30-A2041
30-A2112
30-A2107
30-A2101
