510(k) Report

Devices descending from K081582

23 later devices reach Infx-8000V, Infinix-Cfi and Infinix Vfi through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan20110—
+1K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+2K120073Infx-8000V withToshibamedical Systems Corporation2012203
+3K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+3K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+4K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+4K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+5K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+5K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+6K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+6K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+7K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+7K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+7K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+8K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+8K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+9K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+9K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+10K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+10K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+11K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—
+11K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+12K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation20260—