Company profile

DeepHealth, Inc.

DeepHealth, Inc. has 9 AI-enabled medical devices on the FDA list. The first decision was on April 16, 2021 and the most recent on June 15, 2026 (Saige-Dx). Its most common review panel is Radiology (9 devices).

9AI devices

2021First decision

2026Latest decision

1Specialties

Per year

20212022202420252026

DeepHealth, Inc. AI devices per year: 2021 1, 2022 2, 2024 3, 2025 1, 2026 2

By specialty

Radiology9

Related guides

Top radiology devices

Timeline

June 15, 2026 · 510(k) K253825Saige-Dx · Radiology · QDQ
May 21, 2026 · 510(k) K254131BAC · Radiology · QIH
August 11, 2025 · 510(k) K251873Saige-Dx · Radiology · QDQ
December 19, 2024 · 510(k) K243705Saige-Density (2.5.0) · Radiology · QIH
December 19, 2024 · 510(k) K243688Saige-Dx (3.1.0) · Radiology · QDQ
November 18, 2024 · 510(k) K241747Saige-Dx · Radiology · QDQ
December 16, 2022 · 510(k) K222275Saige-Density · Radiology · QIH
May 12, 2022 · 510(k) K220105Saige-Dx · Radiology · QDQ
April 16, 2021 · 510(k) K203517Saige-Q · Radiology · QFM