510(k) Report

Devices descending from K012097

18 later devices reach Vortex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061421Erad PacsErad, Inc.200614—
+1K053281Evms (Enterprise Visual Medical System Software)Emageon, Inc.200509
+1K042008UltravisualEmageon Uv, Inc.20041—
+1K031778Practicebuilder 1-2-3Erad Imagemedical Corp.20030—
+2K141329RadspaTelerad Tech Private Limited20140—
+2K132799Clariso PacsClariso, Inc.20134—
+2K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc.20127—
+3K241223eRAD PACSErad, Inc.20240—
+3K161341Lifesys PacsLifetrack Medical Systems, Inc.20170—
+3K152977DG PacsDicom Grid, Inc.201641
+3K151957BOX DICOM ViewerBox, Inc.20153—
+4K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health202021
+4K200822BraidBraid.Health20201—
+4K201296i-Rapha SolutionIrm, Inc.20200—
+4K180549ZED LinkZed Technologies20180—
+5K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+5K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+5K231360Ambra PACSDicom Grid Dba Ambra Health202301