510(k) Report

Devices descending from K912944

39 later devices reach CT 8000 Digital Injection System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070798Adapters for CT, Angiographic, and/or Mri Power InjectorsCoeur, Inc.20072—
+1K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.200518—
+1K031339OptibolusMallinckrodt Inc., Liebel-Flarsheim Business2003121
+1K022116Elph Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business20020—
+1K9838263S Injector-CT Contrast Delivery SystemUnimachs Corp.200019—
+1K963071Angiomat IllumenaMallinckrodt Inc., Liebel-Flarsheim Business199732
+2K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)Nemoto Kyorindo Co., Ltd.20240—
+2K173450PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd.20180—
+2K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…Coeur, Inc.20170—
+2K140469MR Syringe Dual PackCoeur, Inc.20140—
+2K133600Coeur, Inc. Frontload for Optivantage Power InjectorCoeur, Inc.20140—
+2K092896Rempress and Angiography Contrast Delivery System RempressNemoto Kyorindo Co., Ltd.20101—
+2K082212Syringe with Handi-FilMallinckrodt Inc., Liebel-Flarsheim Business20090—
+2K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd.200815—
+2K042744Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business2004111
+3K172694Sterile Disposable SyringesShenyang Mastech Medical Device Co., Ltd.20180—
+3K152906Disposable High Pressure Injector SyringeWuxi Yushou Medical Appliances Co., Ltd.20160—
+3K160190Sunmed Control SyringesSunny Medical Device (Shenzhen) Co., Ltd.20160—
+3K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.20168—
+3K082439Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA, CT-200+200-MA…Shandong Weigao Medical Polymer Co., Ltd.20092—
+3K072886Medrad Stellant CT Injector System with P3TMedrad, Inc.20077—
+3K063503Optivantage DH Injector System with Enhanced CommunicationMallinckrodt Inc., Liebel-Flarsheim Business200721
+4K201395Sterile High-pressure Angiographic Syringes for single-useYouwo (Guangzhou) Medical Device Co., Ltd.20200—
+4K192657Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.20204—
+4K182289Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.20180—
+4K170279Disposable High Pressure SyringeUnion Medical Shenzhen Co., Ltd.20170—
+4K162088Ecomed Disposable Angiographic SyringesEcomed Solutions, LLC20170—
+4K152361OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling…Liebel-Flarsheim Company, LLC20160—
+4K082905Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc.200952
+4K082458P3T AbdomenMedrad, Inc.20080—
+5K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…Fortis Biosolutions Company Limited20260—
+5K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.20212—
+5K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc.201841
+6K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.20260—
+6K241109Single-use Sterile High-pressure Angiographic Syringes and AccessoriesShenzhen Boon Medical Supply Co., Ltd.20240—
+6K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc.201831
+7K210541ulrichINJECT CT motionUlrich GmbH & Co. KG20211—
+7K192370MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc.201901
+8K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG20250—