Medical Device Manufacturer · US , Cambridge , MA

DeepHealth, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2021

Recent clearances: BAC, Saige-Dx, TechLive

Total

Cleared

Denied

DeepHealth, Inc. has 10 FDA 510(k) cleared radiology devices. Based in Cambridge, US.

Latest FDA clearance: Jun 2026. Active since 2021.

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

1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

DeepHealth, 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 - DeepHealth, Inc.

10 devices

1-10 of 10

Saige-Density (2.5.0)

DeepHealth, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - DeepHealth, Inc.

Filters