510(k) Report

Devices descending from K993765

113 later devices reach Quantitative Analysis of Left Ventricular Angiograms (QLV) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K240791ADAS 3DAdas3D Medical S.L.20241—
+8K232147CAAS WorkstationPie Medical Imaging BV20241—
+8K202789Monaco Rtp SystemElekta Solutions AB20213—
+8K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+9K253969ADAS 3DAdas3D Medical S.L.20260—
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K243769QFR (3.0)Qfr Solutions BV20250—
+9K213787Monaco RTP SystemElekta Solutions AB20222—
+9K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+10K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+10K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+10K223233Monaco RTP SystemElekta Solutions AB20231—
+11K252002Monaco RTP System (6.3)Elekta Solutions AB20260—