Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1650](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1650) → IZQ — Injector, Contrast Medium, Automatic # IZQ · Injector, Contrast Medium, Automatic _Cardiovascular · 21 CFR 870.1650 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ ## Overview - **Product Code:** IZQ - **Device Name:** Injector, Contrast Medium, Automatic - **Regulation:** [21 CFR 870.1650](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1650) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Special Controls *Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Recent Cleared Devices (20 of 22) Showing 20 most recent of 22 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252281](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K252281.md) | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | Nov 18, 2025 | SESE | | [K251295](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K251295.md) | ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG | Nov 7, 2025 | SESE | | [K252689](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K252689.md) | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. | Sep 24, 2025 | SESE | | [K241849](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K241849.md) | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. | Nov 5, 2024 | SESE | | [K241850](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K241850.md) | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | Aug 26, 2024 | SESE | | [K233737](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K233737.md) | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | Apr 19, 2024 | SESE | | [K210541](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K210541.md) | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | Aug 6, 2021 | SESE | | [K192872](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K192872.md) | ulrichINJECT CT Motion | Ulrich GmbH & Co. KG | Jul 2, 2020 | SESE | | [K171392](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K171392.md) | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | Nov 9, 2017 | SESE | | [K151048](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K151048.md) | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set | Bracco Injeneering | Jan 22, 2016 | SESE | | [K152361](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K152361.md) | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System | Liebel-Flarsheim Company, LLC | Jan 14, 2016 | SESE | | [K091734](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K091734.md) | SONIC SHOT GX | Nemoto Kyorindo Co., Ltd. | May 21, 2010 | SESE | | [K063503](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K063503.md) | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION | Mallinckrodt Inc., Liebel-Flarsheim Business | Apr 27, 2007 | SESE | | [K062449](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K062449.md) | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | E-Z-Em, Inc. | Apr 13, 2007 | SESE | | [K063090](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K063090.md) | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY | Medrad, Inc. | Mar 27, 2007 | SESE | | [K062265](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K062265.md) | CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM | Swiss Medical Care S.A. | Dec 26, 2006 | SESE | | [K031571](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K031571.md) | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | E-Z-Em, Inc. | Jun 19, 2003 | SESE | | [K983314](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K983314.md) | PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM | Nycomed Amersham Imaging | Feb 19, 1999 | SESE | | [K984058](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K984058.md) | ACIST INJECTOR SYSTEM, MODEL CL100 H | Acist Medical Systems | Feb 11, 1999 | SESE | | [K951005](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ/K951005.md) | KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) | Kenex , Ltd. | May 4, 1995 | SESE | ## Top Applicants - Ulrich GmbH & Co. KG — 7 clearances - Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances - E-Z-Em, Inc. — 2 clearances - Imaxeon Pty, Ltd. — 2 clearances - Acist Medical Systems — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/IZQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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