Section 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 .63 FR 23387, Apr. 29, 1998, as amended at 84 FR 71819 , Dec. 30, 2019 As amended at 84 FR 71819 , 12/30/2019