{"data":{"id":"us/21-cfr-892.1000","jurisdiction":"us","citation":"21 CFR 892.1000","heading":"Magnetic resonance diagnostic device.","body":"(a) Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).\n(b) Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only 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":"7ce1d1d4404ee12c1b68c05318a96639846efda5eba2576f4b4e2f01dcac2c18","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-892.9","next":"us/21-cfr-892.1001"},"notice":"GroundRules: Original legal text. Not legal advice."}