Angiographic Injection System, Model R-2000
by ACIST Medical Systems, Inc.
510(k) K000013
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000013 | Date28 Mar 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Acist Angiographic Injection System, Model R-2000
- 510(k) Number
- FDA product code
- DXT
- FDA applicant
- Acist Medical Systems
- 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
This device is an Injector and Syringe, Angiographic, designed to deliver contrast media during angiographic procedures. It automates precise injection of contrast agents into blood vessels, enabling clear visualization of coronary and peripheral vasculature for diagnostic and interventional cardiology.
The Model R-2000 is intended for use in clinical settings such as catheterization labs, where it is supplied as a reusable medical device. It operates under sterile conditions when prepared for patient use and is classified as a Class II device under FDA regulations (21 CFR 870.1650). The system is regulated via FDA 510(k) clearance (K000013) and adheres to cardiovascular specialty standards.
From the manufacturer
ACIST Medical Systems provides innovative contrast injector & IVUS catheter diagnostic technologies to visualize, assess & improve patient treatment.
Other devices from ACIST Medical Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
What clinical environments is the ACIST Angiographic Injection System, Model R-2000, designed for use in and why?
The Model R-2000 is specifically designed for use in catheterization labs, where angiographic procedures are performed. This is because it automates the precise injection of contrast media into blood vessels, enabling clear visualization of coronary and peripheral vasculature—critical for diagnostic and interventional cardiology in these controlled settings.
Is the ACIST Angiographic Injection System, Model R-2000, intended for single-use or reusable applications, and how does this affect its use?
The Model R-2000 is a reusable medical device, meaning it is designed for multiple uses in clinical settings. This allows for cost-effective operation and consistent performance across procedures, provided it is properly maintained and prepared under sterile conditions for each patient use.
What regulatory pathway does the ACIST Angiographic Injection System, Model R-2000, follow, and what does this imply for its use?
The Model R-2000 follows the FDA 510(k) clearance pathway, specifically classified as a Class II device under 21 CFR 870.1650. This implies it has undergone rigorous review by the FDA’s Cardiovascular (CV) advisory committee to demonstrate substantial equivalence to a predicate device, ensuring its safety and effectiveness for angiographic contrast media injection in clinical practice.
How is the ACIST Angiographic Injection System, Model R-2000, prepared for patient use, and what does this involve?
The Model R-2000 is intended to be used under sterile conditions when preparing for patient use. While it is reusable, each procedure requires proper sterilization and setup to maintain hygiene and safety standards, ensuring the device is free from contamination before injection of contrast media during angiographic procedures.
What types of procedures is the ACIST Angiographic Injection System, Model R-2000, primarily intended to support, and why?
The Model R-2000 is primarily intended to support angiographic procedures, including coronary and peripheral angiography. It automates the injection of contrast media, which enhances visualization of blood vessels during diagnostic and interventional cardiology, improving the accuracy and efficiency of these critical procedures.