Catalogue values for Mobile Digital Radiography System (V2)

Category Specification Bid Requirement (Allowed Values)
General Product Description Mobile Digital Radiography System
Scope of supply Compact, easily transportable, digital mobile radiographic unit with articulated/telescopic arm
Digital Detector Detector Size 14 inches x 17 inches(wireless )
Matrix size 2kx2k
X Ray Generator and Tubes Anode Type Rotating
Workstation Number of images which can be stored 3000 or more, 5000 or more, 10000 or more
Certifications Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
Availability of valid Medical Device license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
Certification for manufacturing unit ISO:13485 (Latest)
Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date Yes
Conformity to Safety Standards IEC 60601-2-54 or equivalent BIS
Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement Yes
AERB Type Approved Equipment Yes
Conformity to Indian Standard IS 7620- Part 1, Part 2, Part 3 Yes
Warranty Warranty in Years 5 Or higher