21 C.F.R. § 892.2030 Medical image digitizer.
Title 21 - Food and Drugs
(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.). [63 FR 23387, Apr. 29, 1998]
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.2030 Medical image digitizer.
