Singular Health Group Submits 510(k) Premarket Notification to US FDA for 3DICOM MD Cloud Imaging Platform

MT Newswires Live

2025/11/28

Singular Health Group (ASX:SHG) submitted a 510(k) premarket notification to the US Food and Drug Administration for its 3DICOM MD Cloud, which expands imaging capability to include additional modalities such as X-ray and ultrasound, alongside the existing computed tomography, magnetic resonance imaging, and positron emission tomography capabilities, according to a Friday Australian bourse filing.

3DICOM MD Cloud provides a browser-based, cloud platform to retrieve and view medical images. It is an advanced version of its existing software-as-a-medical-device 3DICOM MD Viewer, built on a cloud-native technical foundation.

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