§892.2030. Medical image digitizer.
21 C.F.R. § 892.2030
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.
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.
Notes, amendments, and revision history
Amendments
[63 FR 23387, Apr. 29, 1998, as amended at 84 FR 71819, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.
Amendments
[63 FR 23387, Apr. 29, 1998, as amended at 84 FR 71819, Dec. 30, 2019]