510(k) Report

Devices descending from K122866

11 later devices reach Vivix-S with Vxvue through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152894Vivix-S 1717NVieworks Co., Ltd.20169—
+1K152855Vivix-S 1012NVieworks Co., Ltd.20165—
+2K200418Vivix-S VWVieworks Co., Ltd.20204—
+2K181003Vivix-S 1717VVieworks Co., Ltd.20187—
+2K163703Vivix-S 1417NVieworks Co., Ltd.20175—
+3K241980!M1Solutions For Tomorrow AB20251—
+3K220239Solid State X-ray Imager (Model: FXRD-4386WB)Vieworks Co., Ltd.20221—
+3K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd.20222—
+3K211790DX-D Imaging Package with XD DetectorsAgfa N.V.20210—
+4K260820Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.20260—
+4K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB20250—