Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of

Topic: Product safety
Regulator: FDA
Published: 30 October 2026
For: Imports
Where it applies: United States
Source: FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA) is classifying the radiology software for referral of findings related to fibrotic lung disease into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the radiology software for referral of findings related to fibrotic lung disease. We are taking this action because we have determined that classifying the device into class II will pr

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Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease

From the notice

Olive tells you which of these hit your products.

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