Title 21: Food and Drugs
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/ PART 892 - RADIOLOGY DEVICES
/ Subpart B - Diagnostic Devices / § 892.2030 Medical image digitizer.
§ 892.2030 Medical image digitizer.
(a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.
(b) Classification. Class II (special controls; voluntary standards - Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.