federal_register: 98-11317

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
98-11317 Radiology Devices; Classifications for Five Medical Image Management Devices Rule The Food and Drug Administration (FDA) is classifying five radiology devices that provide functions related to medical image communication, storage, processing, and display into class I (general controls) or class II (special controls). The medical image storage device and medical image communications device are classified into class I, and they are exempted from the requirement of premarket notification when they do not use irreversible compression. The medical image digitizer, the medical image hardcopy device, and the picture archiving and communications system are classified into class II. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990. 1998-04-29 1998 4 https://www.federalregister.gov/documents/1998/04/29/98-11317/radiology-devices-classifications-for-five-medical-image-management-devices https://www.govinfo.gov/content/pkg/FR-1998-04-29/pdf/98-11317.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying five radiology devices that provide functions related to medical image communication, storage, processing, and display into class I (general controls) or class II (special controls). The medical...  

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