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The FDA has determined that the FDR CROSS (DR-XD 3000) is substantially equivalent to legally marketed devices, allowing it to be marketed under the general controls provisions of the Federal Food, Drug, and Cosmetic Act. This mobile X-ray fluoroscopy system is intended for various medical imaging procedures, excluding cardiac procedures, and features a detachable flat panel sensor. The device meets several voluntary standards and has undergone necessary verification and validation activities, concluding it
- Author
- Rex Lopez
- Language
- EN