ClearanceBrief
Company ยท US

DeepHealth, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2026. Name variants (Inc, Corp, punctuation) are merged.

10510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer5
QIHAutomated Radiological Image Processing Software3
LLZSystem, Image Processing, Radiological1
QFMRadiological Computer-Assisted Prioritization Software For Lesions1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 15, 2026K253825Saige-Dx
DeepHealth, Inc.
QDQ
May 21, 2026K254131BAC
DeepHealth, Inc.
QIH
Aug 11, 2025K251873Saige-Dx
DeepHealth, Inc.
QDQ
Jun 5, 2025K243703TechLive
DeepHealth, Inc.
LLZ
Dec 19, 2024K243705Saige-Density (2.5.0)
DeepHealth, Inc.
QIH
Dec 19, 2024K243688Saige-Dx (3.1.0)
DeepHealth, Inc.
QDQ
Nov 18, 2024K241747Saige-Dx
DeepHealth, Inc.
QDQ
Dec 16, 2022K222275Saige-Density
DeepHealth, Inc.
QIH
May 12, 2022K220105Saige-Dx
DeepHealth, Inc.
QDQ
Apr 16, 2021K203517Saige-Q
DeepHealth, Inc.
QFM

Latest recalls

DateFirm and productCodeLinked 510(k)
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