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Philips Healthcare received FDA clearance for the DigitalDiagnost C50, a Class II stationary x-ray system, confirming its substantial equivalence to previously marketed devices. The device is designed for generating radiographic images and includes components such as a ceiling suspension with x-ray assembly and an acquisition workstation. Compliance with general controls of the Federal Food, Drug, and Cosmetic Act is required for marketing the device.
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- alcolyt m
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- EN