510(k) Report

Devices descending from K993728

39 later devices reach Medrad Envision CT Injector System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133600Coeur, Inc. Frontload for Optivantage Power InjectorCoeur, Inc.20140—
+1K070798Adapters for CT, Angiographic, and/or Mri Power InjectorsCoeur, Inc.20072—
+1K023183Medrad Stellant CT Injector SystemMedrad, Inc.2003366
+2K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…Coeur, Inc.20170—
+2K052633Dual Shot - Contrast Delivery SystemNemoto Kyorindo Co., Ltd.20053—
+2K033881Medrad Stellant CT Injector System with Imaging System Interface ModuleMedrad, Inc.2004341
+2K031483Medrad Manual Syringe LoaderMedrad, Inc.20030—
+3K072886Medrad Stellant CT Injector System with P3TMedrad, Inc.20077—
+3K063090Medrad Stellant CT Injector System with XDS AccessoryMedrad, Inc.20076—
+3K061976Ckis-004A Injector Synchronization OptionToshiba America Medical Systems, In.C20061—
+3K062168Contrast Delivery System - Dual Shot AlphaNemoto Kyorindo Co., Ltd.20062—
+3K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.200518—
+4K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)Nemoto Kyorindo Co., Ltd.20240—
+4K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc.201841
+4K140469MR Syringe Dual PackCoeur, Inc.20140—
+4K133189Dual Shot Alpha 7Nemoto Kyorindo Co., Ltd.20141—
+4K082905Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc.200952
+4K082960GE Xtreme Injector OptionGe Medical Systems, LLC20080—
+4K082458P3T AbdomenMedrad, Inc.20080—
+4K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd.200815—
+5K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc.201831
+5K172694Sterile Disposable SyringesShenyang Mastech Medical Device Co., Ltd.20180—
+5K173450PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd.20180—
+5K152906Disposable High Pressure Injector SyringeWuxi Yushou Medical Appliances Co., Ltd.20160—
+5K160190Sunmed Control SyringesSunny Medical Device (Shenzhen) Co., Ltd.20160—
+5K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.20168—
+5K082439Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA, CT-200+200-MA…Shandong Weigao Medical Polymer Co., Ltd.20092—
+6K210541ulrichINJECT CT motionUlrich GmbH & Co. KG20211—
+6K201395Sterile High-pressure Angiographic Syringes for single-useYouwo (Guangzhou) Medical Device Co., Ltd.20200—
+6K192657Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.20204—
+6K192370MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc.201901
+6K182289Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.20180—
+6K170279Disposable High Pressure SyringeUnion Medical Shenzhen Co., Ltd.20170—
+6K162088Ecomed Disposable Angiographic SyringesEcomed Solutions, LLC20170—
+7K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…Fortis Biosolutions Company Limited20260—
+7K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG20250—
+7K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.20212—
+8K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.20260—
+8K241109Single-use Sterile High-pressure Angiographic Syringes and AccessoriesShenzhen Boon Medical Supply Co., Ltd.20240—