510(k) Report

Devices descending from K983314

11 later devices reach Premica CT Contrast Media Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062265CT Expres Iii Contrast Media Delivery SystemSwiss Medical Care S.A.200610—
+2K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP…Bracco Injeneering20169—
+3K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…Imaxeon Pty, Ltd.20241—
+3K171392ulrichINJECT CT motionUlrich GmbH & Co. KG20176—
+4K252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…Imaxeon Pty, Ltd.20250—
+4K192872ulrichINJECT CT MotionUlrich GmbH & Co. KG20205—
+5K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…Ulrich GmbH & Co. KG20242—
+5K210541ulrichINJECT CT motionUlrich GmbH & Co. KG20211—
+6K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG20250—
+6K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…Ulrich GmbH & Co. KG20241—
+7K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…Ulrich GmbH & Co. KG20250—