FDA.reportPublic FDA data

510(k) K233737

Device
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
Applicant
Ulrich GmbH & Co. KG
510(k) number
K233737
Product code
IZQ
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-19
Date received
2023-11-22
Regulation
870.1650
Classification name
Injector, Contrast Medium, Automatic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sven Erdmann
Address
Buchbrunnenweg 12 Ulm DE 89081 89081

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IZQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG2025-11-18
K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG2025-11-07
K252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.2025-09-24
K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.2024-11-05
K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG2024-08-26
K210541ulrichINJECT CT motionUlrich GmbH & Co. KG2021-08-06
K192872ulrichINJECT CT MotionUlrich GmbH & Co. KG2020-07-02
K171392ulrichINJECT CT motionUlrich GmbH & Co. KG2017-11-09
K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient SetBracco Injeneering2016-01-22
K152361OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base SystemLiebel-Flarsheim Company, LLC2016-01-14
K091734SONIC SHOT GXNemoto Kyorindo Co., Ltd.2010-05-21
K063503OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATIONMallinckrodt Inc., Liebel-Flarsheim Business2007-04-27
K062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730E-Z-Em, Inc.2007-04-13
K063090MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORYMedrad, Inc.2007-03-27
K062265CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEMSwiss Medical Care S.A.2006-12-26