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System, Digital Image Communications, Radiological

System, Digital Image Communications, Radiological is a medical device type in the Radiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
System, Digital Image Communications, Radiological
Radiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

LMD

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Class 1

21 CFR 892.2020

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Radiology

Device Characteristics

No

No

No

Not Eligible

Definition

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions.