§ 892.2030. Medical image digitizer.
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/us/cfr/t21/s§ 892.2030·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [63 FR 23387, Apr. 29, 1998, as amended at 84 FR 71819, Dec. 30, 2019]