Medical Device Manufacturer · US , Menlo Park , CA

Subtle Medical, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2018

Recent clearances: SubtleHD-CT (1.x), SubtleHD-PET (1.x), SubtleHD (1.x)

Total

Cleared

Denied

Subtle Medical, Inc. has 11 FDA 510(k) cleared radiology devices. Based in Menlo Park, US.

Latest FDA clearance: May 2026. Active since 2018.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Enzyme Corporation and Decus Biomedical, Inc.. 2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

Subtle Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Subtle Medical, Inc.

11 devices

1-11 of 11

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Jun 05, 2026

Subtle Medical, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Subtle Medical, Inc.

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