ACIST RXi Mini System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K172216 ↗

FDA product code

DRQ

Device class

Class II

Regulation

21 CFR Part 870.2060

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Manufacturer's product page: ACIST RXi®

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See all devices from ACIST Medical Systems, Inc. →

• What is the primary clinical application of the ACIST RXi Mini System in a catheterization lab setting?

  The ACIST RXi Mini System is designed to process and amplify signals from intravascular sensors, enabling accurate real-time interpretation of physiological measurements during cardiovascular diagnostics. Specifically, it supports rapid exchange systems and Fractional Flow Reserve (FFR) assessments, which are critical for evaluating coronary artery blockages and guiding interventional procedures like angioplasty or stent placement.

• Is the ACIST RXi Mini System intended for single-use or reusable applications, and what does this mean for maintenance?

  The ACIST RXi Mini System is explicitly supplied as a reusable medical device. This means it is engineered for repeated use in catheterization labs after proper cleaning, disinfection, and maintenance as outlined in the manufacturer’s instructions. Reusability helps reduce waste and costs while ensuring consistent performance across procedures.

• How does the compact design of the ACIST RXi Mini System benefit catheterization lab workflows?

  The ACIST RXi Mini System’s compact design minimizes the physical footprint in the catheterization lab without compromising core functionality. This allows for efficient use of space, easier integration with existing equipment, and reduced clutter—particularly valuable in labs where multiple devices and personnel operate simultaneously during complex procedures like FFR assessments.

• What regulatory pathway was followed for FDA clearance of the ACIST RXi Mini System, and what does this imply for its safety and performance?

  The device received FDA clearance through a 510(k) premarket submission (K172216), classified under Class II (DRQ) with a substantially equivalent determination by the Cardiovascular (CV) Advisory Committee. This pathway ensures the device meets established safety and effectiveness standards for amplifiers and signal conditioners in cardiovascular diagnostics, as determined by the FDA’s review of clinical data and technical specifications.

• Are there any compatibility considerations for the ACIST RXi Mini System when used alongside other devices in the lab?

  The system is designed to interface with microcatheters and intravascular ultrasound (IVUS) devices, but its compatibility with MRI environments is not specified. Clinicians should verify that the lab’s specific equipment and protocols align with the device’s intended use—particularly if MRI-compatible sensors or tools are involved—to avoid potential interference or safety risks.