Atlas FDA

IZQ

23 FDA 510(k) clearances · Product code

147 daysmedian time to decision
268 days90th percentile
23clearances measured

FDA profile

Official device name
Injector, Contrast Medium, Automatic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1650
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 14 · 2022: 24 · 2023: 16 · 2024: 23 · 2025: 21 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
VueJect® Ultrasound Enhancing Agent Delivery System (K262115)ACIST Medical Systems, Inc.2026-08-03
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (K252281)Ulrich GmbH & Co. KG2025-11-18
ulrichINJECT CT Motion (XD 8000) (K251295)Ulrich GmbH & Co. KG2025-11-07
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (K252689)Imaxeon Pty, Ltd.2025-09-24
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (K241849)Imaxeon Pty, Ltd.2024-11-05
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (K241850)Ulrich GmbH & Co. KG2024-08-26
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (K233737)Ulrich GmbH & Co. KG2024-04-19
ulrichINJECT CT motion (K210541)Ulrich GmbH & Co. KG2021-08-06
ulrichINJECT CT Motion (K192872)Ulrich GmbH & Co. KG2020-07-02
ulrichINJECT CT motion (K171392)Ulrich GmbH & Co. KG2017-11-09
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set (K151048)Bracco Injeneering2016-01-22
OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System (K152361)Liebel-Flarsheim Company, LLC2016-01-14
SONIC SHOT GX (K091734)Nemoto Kyorindo Co., Ltd.2010-05-21
OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION (K063503)Mallinckrodt Inc., Liebel-Flarsheim Business2007-04-27
EMPOWERMR INJECTOR SYSTEM, MODEL 9730 (K062449)E-Z-Em, Inc.2007-04-13
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY (K063090)Medrad, Inc.2007-03-27
CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM (K062265)Swiss Medical Care S.A.2006-12-26
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 (K031571)E-Z-Em, Inc.2003-06-19
PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM (K983314)Nycomed Amersham Imaging1999-02-19
ACIST INJECTOR SYSTEM, MODEL CL100 H (K984058)Acist Medical Systems1999-02-11
KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) (K951005)Kenex , Ltd.1995-05-04
MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N (K760643)Bd Becton Dickinson Vacutainer Systems Preanalytic1976-10-08
MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N (K760641)Bd Becton Dickinson Vacutainer Systems Preanalytic1976-10-08

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Every clearance here is in the API, with alerts when new ones post.