{"data":{"id":"us/21-cfr-892.2030","jurisdiction":"us","citation":"21 CFR 892.2030","heading":"Medical image digitizer.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 892—RADIOLOGY DEVICES","Subpart B—Diagnostic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"fdb2eb33663a74f6f42dbea28d9c8f18ae49340b83cdef8ae1eb7f15ec34a0e1","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-892.2020","next":"us/21-cfr-892.2040"},"notice":"GroundRules: Original legal text. Not legal advice."}