510(k) Report

Devices descending from DEN180005

50 later devices reach OsteoDetect through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240712icobrain ariaIcometrix NV20240—
+1K193417FractureDetect (FX)Imagen Technologies, Inc.20208—
+1K182373PowerLook Tomo Detection V2 SoftwareIcad, Inc.20187—
+1K181704TransparaScreenpoint Medical B.V.201832—
+2K241770Prostate MR AI (VA10A)Siemens Healthcare GmbH20250—
+2K220164RayvolveAzmed Sas20223—
+2K220105Saige-DxDeepHealth, Inc.20224—
+2K212365BoneViewGleamer20223—
+2K210670BU-CADTaihao Medical, Inc.20213—
+2K201019Genius AI DetectionHologic, Inc.20203—
+2K192854MammoScreenTherapixel20204—
+2K193229TransparaScreenpoint Medical B.V.20209—
+2K192287TransparaScreenpoint Medical B.V.20196—
+2K191994ProFound AI Software V2.1Icad, Inc.20192—
+3K260086CadAI-B DxBeamWorks, Inc.20260—
+3K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+3K241747Saige-DxDeepHealth, Inc.20243—
+3K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+3K240845RayvolveAzmed Sas20242—
+3K223491Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1…Ge Medical Systems, LLC20230—
+3K222176BoneViewGleamer20231—
+3K221449Genius AI Detection 2.0Hologic, Inc.20222—
+3K212783ProstatIDScanmed, LLC20222—
+3K211541MammoScreen 2.0Therapixel20213—
+3K211678Lunit INSIGHT MMGLunit, Inc.20215—
+3K210404Transpara 1.7.0Screenpoint Medical B.V.20215—
+3K203822ProFound AI Software V3.0Icad, Inc.20211—
+4K260378RayvolveAZmed20261—
+4K253682DeepHealth ProstateAIQuantib B.V.20260—
+4K260320Lunit INSIGHT MMG (v1.1.10)Lunit, Inc.20260—
+4K243341Genius AI Detection 2.0Hologic, Inc.20250—
+4K242683QP-Prostate® CADQuibim S.L.20250—
+4K242171TechCare TraumaMilvue20250—
+4K243688Saige-Dx (3.1.0)DeepHealth, Inc.20242—
+4K240417ProFound Detection (V4.0)Icad, Inc.20240—
+4K240301MammoScreen® (3)Therapixel20242—
+4K231470Lunit INSIGHT DBTLunit, Inc.20233—
+4K230096Genius AI Detection 2.0 with CC-MLO CorrelationHologic, Inc.20230—
+4K221347Transpara 1.7.2Screenpoint Medical B.V.20224—
+5K261378Rayvolve AZchestAZmed20260—
+5K251873Saige-DxDeepHealth, Inc.20251—
+5K243679MammoScreen® (4)Therapixel20251—
+5K241831Transpara (2.1.0)Screenpoint Medical B.V.20242—
+5K242652Lunit INSIGHT DBT v1.1Lunit, Inc.20242—
+6K261517qCT Lung (v1.0)Qure.Ai Technologies Pvt., Ltd.20260—
+6K260898Transpara (2.1.0)Screenpoint Medical B.V.20260—
+6K260714MammoScreen® (5)Therapixel20260—
+6K253825Saige-DxDeepHealth, Inc.20260—
+6K253796Lunit INSIGHT DBT (V1.2)Lunit, Inc.20260—
+6K251474Median LCS (internal name) / eyonis LCS (trade name) (1.0)Median Technologies20260—