510(k) Report

Devices descending from K181704

32 later devices reach Transpara through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241770Prostate MR AI (VA10A)Siemens Healthcare GmbH20250—
+1K220105Saige-DxDeepHealth, Inc.20224—
+1K210670BU-CADTaihao Medical, Inc.20213—
+1K192854MammoScreenTherapixel20204—
+1K193229TransparaScreenpoint Medical B.V.20209—
+1K192287TransparaScreenpoint Medical B.V.20196—
+2K260086CadAI-B DxBeamWorks, Inc.20260—
+2K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+2K241747Saige-DxDeepHealth, Inc.20243—
+2K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+2K212783ProstatIDScanmed, LLC20222—
+2K211541MammoScreen 2.0Therapixel20213—
+2K211678Lunit INSIGHT MMGLunit, Inc.20215—
+2K210404Transpara 1.7.0Screenpoint Medical B.V.20215—
+3K253682DeepHealth ProstateAIQuantib B.V.20260—
+3K260320Lunit INSIGHT MMG (v1.1.10)Lunit, Inc.20260—
+3K242683QP-Prostate® CADQuibim S.L.20250—
+3K243688Saige-Dx (3.1.0)DeepHealth, Inc.20242—
+3K240301MammoScreen® (3)Therapixel20242—
+3K231470Lunit INSIGHT DBTLunit, Inc.20233—
+3K221347Transpara 1.7.2Screenpoint Medical B.V.20224—
+4K251873Saige-DxDeepHealth, Inc.20251—
+4K243679MammoScreen® (4)Therapixel20251—
+4K241831Transpara (2.1.0)Screenpoint Medical B.V.20242—
+4K242652Lunit INSIGHT DBT v1.1Lunit, Inc.20242—
+4K230096Genius AI Detection 2.0 with CC-MLO CorrelationHologic, Inc.20230—
+5K261517qCT Lung (v1.0)Qure.Ai Technologies Pvt., Ltd.20260—
+5K260898Transpara (2.1.0)Screenpoint Medical B.V.20260—
+5K260714MammoScreen® (5)Therapixel20260—
+5K253825Saige-DxDeepHealth, Inc.20260—
+5K253796Lunit INSIGHT DBT (V1.2)Lunit, Inc.20260—
+5K251474Median LCS (internal name) / eyonis LCS (trade name) (1.0)Median Technologies20260—