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

10
Total
10
Cleared
0
Denied

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

10 devices
1-10 of 10
Cleared Jun 15, 2026
Saige-Dx
K253825 · QDQ
Radiology · 196d
Cleared May 21, 2026
BAC
K254131 · QIH
Radiology · 150d
Cleared Aug 11, 2025
Saige-Dx
K251873 · QDQ
Radiology · 54d
Cleared Jun 05, 2025
TechLive
K243703 · LLZ
Radiology · 188d
Cleared Dec 19, 2024
Saige-Dx (3.1.0)
K243688 · QDQ
Radiology · 20d
Cleared Dec 19, 2024
Saige-Density (2.5.0)
K243705 · QIH
Radiology · 20d
Cleared Nov 18, 2024
Saige-Dx
K241747 · QDQ
Radiology · 153d
Cleared Dec 16, 2022
Saige-Density
K222275 · QIH
Radiology · 140d
Cleared May 12, 2022
Saige-Dx
K220105 · QDQ
Radiology · 120d
Cleared Apr 16, 2021
Saige-Q
K203517 · QFM
Radiology · 137d
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