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Angiographic Injection System, Model R2000-CMS

by ACIST Medical Systems, Inc.

510(k) K010390

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK010390 Date9 Mar 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0643-2009 FDA Unclassified (pre-2012) initiated 10 Nov 2008

    Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in multiple injections of contract media when one injection was intended.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Acist Angiographic Injection System, Model R2000-Cms
510(k) Number
FDA product code
DXT
Device class
Class II
Regulation
21 CFR Part 870.1650
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Angiographic Injection System, Model R2000-CMS, is an Injector and Syringe, Angiographic (OpenFDA classification: Device Class II). It is designed to deliver contrast media during angiographic procedures, facilitating the visualization of blood vessels for diagnostic and interventional cardiovascular assessments.

This system is intended for use in clinical settings, typically within cardiac catheterization labs. It operates as a reusable device, requiring appropriate sterilization and maintenance protocols. The Model R2000-CMS holds FDA 510(k) clearance (K010390) under the Cardiovascular advisory committee review, with a Special 510(k) classification. No MRI safety or single-use specifications are indicated in the regulatory data.

From the manufacturer

ACIST Medical Systems provides innovative contrast injector & IVUS catheter diagnostic technologies to visualize, assess & improve patient treatment.

Source: acist.com

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