federal_register: 96-30650
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 96-30650 | Radiology Devices; Proposed Classifications for Five Medical Image Management Devices | Proposed Rule | The Food and Drug Administration is proposing to classify five generic types of radiology devices that provide functions related to medical image communication, storage, processing, and display. Under the proposal, the medical image storage device and the medical image communications device would be classified into class I (general controls), and would be 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 would be classified into class II (special controls). The agency is publishing in this document the recommendations of the Radiology Devices Panel regarding the classification of these devices. After considering public comments on the proposed classifications, FDA will publish a final regulation classifying these devices. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices. | 1996-12-02 | 1996 | 12 | https://www.federalregister.gov/documents/1996/12/02/96-30650/radiology-devices-proposed-classifications-for-five-medical-image-management-devices | https://www.govinfo.gov/content/pkg/FR-1996-12-02/pdf/96-30650.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration is proposing to classify five generic types of radiology devices that provide functions related to medical image communication, storage, processing, and display. Under the proposal, the medical image storage device and... |