# Radiology Devices; Classifications for Five Medical Image Management Devices
> **Food and Drug Administration** · Final rule. · Published 1998-04-29 · Effective 1998-05-29 · 63 FR 23385
## Document
- **Document number:** 98-11317
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 23385
- **CFR reference:** 21 CFR 892
- **Publication date:** 1998-04-29
- **Effective date:** 1998-05-29
- **HHS docket:** Docket No. 96N-0320
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/04/29/98-11317/radiology-devices-classifications-for-five-medical-image-management-devices)
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