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Subtle Medical, Inc. FDA Approvals

0 new drug approvals and 9 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
SubtleHD-CT (1.x)510(k)May 15, 2026Radiology
SubtleHD-PET (1.x)510(k)May 14, 2026Radiology
SubtleHD (1.x)510(k)Feb 12, 2025Radiology
AiMIFY (1.x)510(k)Aug 21, 2024Radiology
SubtleSYNTH (1.x)510(k)Jul 11, 2024Radiology
SubtleREFORMAT (1.x)510(k)Apr 29, 2024Radiology
SubtleMR (2.3.x)510(k)May 11, 2023Radiology
SubtlePET510(k)Sep 28, 2021Radiology
SubtleMR510(k)Feb 26, 2021Radiology

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