Gentoo Contrast Injection System
by ACIST Medical Systems, Inc.
510(k) K020892
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020892 | Date27 Jan 2003 | 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- Withdrawn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 Gentoo Contrast Injection System
- 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
The Gentoo Contrast Injection System is an angiographic injector and syringe designed for precise delivery of contrast media during cardiovascular imaging procedures. It automates the injection process to enhance visualization of blood vessels, supporting diagnostic and interventional cardiology workflows.
This system is intended for single-use in clinical settings, including cardiac catheterization labs. It operates as a reusable device with programmable injection protocols for contrast and saline, supplied with disposable syringe/patient kits. The system is classified as Class II under FDA regulations and holds an FDA 510(k) clearance for use in angiographic procedures. Multiple model variants are listed under the product code DXT.
From the manufacturer
ACIST Medical Systems provides innovative contrast injector & IVUS catheter diagnostic technologies to visualize, assess & improve patient treatment.
Discover ACIST medical products for interventional cardiology, including the CVi, HDi, and RXi systems. We provide expert cath lab solutions. Speak with our experts.
Other devices from ACIST Medical Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of procedures is the ACIST Gentoo Contrast Injection System designed to support in a clinical setting?
The ACIST Gentoo Contrast Injection System is specifically designed to automate the delivery of contrast media during cardiovascular imaging procedures, particularly in cardiac catheterization labs. It enhances visualization of blood vessels by providing precise, programmable injections of contrast and saline, which are critical for diagnostic and interventional cardiology workflows.
Is the ACIST Gentoo Contrast Injection System reusable, or is it intended for single-use?
The system itself is reusable, but it operates with disposable syringe/patient kits for each use. This design ensures single-use safety for patient-facing components while allowing the core injector to be reused across multiple procedures.
How many model variants of the ACIST Gentoo Contrast Injection System are available, and what regulatory pathway was followed for clearance?
Multiple model variants of the Gentoo system are available, as indicated by the product code DXT and the listed FDA 510(k) clearance (K020892). The device was cleared through the Abbreviated 510(k) pathway, with a substantially equivalent determination by the FDA’s Cardiovascular (CV) advisory committee, ensuring compliance with Class II regulatory standards.
What storage or handling requirements should be considered for the disposable components of the ACIST Gentoo system?
While the data does not specify exact storage conditions, the disposable syringe/patient kits—which are intended for single-use—should be stored according to manufacturer guidelines to maintain sterility and functionality. Since the system is designed for clinical use in catheterization labs, proper handling and expiration checks are essential before each procedure.