{"data":{"id":"us/21-cfr-892.1940","jurisdiction":"us","citation":"21 CFR 892.1940","heading":"Radiologic quality assurance instrument.","body":"(a) Identification. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.\n(b) Classification. Class I (general controls). 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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","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":"82e348ae80d5c1f4dbe76ac849584b4c531deee163c0376c47473f36ace7d8bf","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-892.1920","next":"us/21-cfr-892.1950"},"notice":"GroundRules: Original legal text. Not legal advice."}