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 |
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