Medical Device Manufacturer · AU , Subiaco

Singular Health Pty, Ltd. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2022

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Singular Health Pty, Ltd. Radiology ✕

2 devices

1-2 of 2

Cleared Jan 08, 2026

3DICOM MD Cloud

Radiology · 43d

Cleared Oct 25, 2022

Radiology · 70d