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Sign in to claim this brandACIST Medical Systems, Inc.
United States·US-MF-000010784
Last updated September 17, 2026
About
ACIST Medical Systems provides innovative contrast injector & IVUS catheter diagnostic technologies to visualize, assess & improve patient treatment.
From the manufacturer's own website, in their original language. Source
What ACIST Medical Systems, Inc. makes
ACIST Medical Systems produces computer systems for cardiac catheterization laboratories, including mobile angiography contrast medium injection systems and cardiovascular ultrasound imaging devices. Their portfolio also includes single-use intravascular ultrasound imaging catheters, pressure transducer catheters, and associated accessories such as injection system controllers, syringes, and administration sets.
The company’s devices are regulated under FDA’s Class I, II, IIa, and IIb classifications and are listed in the EU’s EUDAQD (eudamed), FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) registry. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does ACIST Medical Systems, Inc. primarily manufacture?
ACIST Medical Systems, Inc. specializes in devices used in cardiac catheterization laboratories. Their portfolio includes computer systems for angiography, such as mobile contrast medium injection systems and cardiovascular ultrasound imaging systems. They also produce single-use intravascular ultrasound imaging catheters, catheter-tip pressure transducers, and related accessories like injection system controllers, syringes, and administration sets. These devices support diagnostic and interventional procedures in cardiovascular care.
Where is ACIST Medical Systems, Inc. based, and how does that affect its regulatory oversight?
ACIST Medical Systems, Inc. is based in the United States. Since the company operates within the U.S., its devices are primarily regulated by the FDA under its classification system (Class I, II, IIa, and IIb). This means compliance with FDA requirements, such as premarket notifications (510(k)) for higher-risk devices, is necessary. The company’s devices are also listed in the FDA’s 510(k) and UDI registries, reflecting their regulatory status in the U.S. market.
Which regulatory registries list ACIST Medical Systems, Inc.’s devices, and why is this important?
ACIST Medical Systems, Inc.’s devices are listed in three key registries: the EU’s eudamed (EUDAQD), the FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) registry. Inclusion in these databases ensures transparency and traceability for regulators, healthcare providers, and patients. For example, eudamed is critical for EU market access, while the FDA registries support compliance with U.S. medical device laws, including post-market surveillance and recalls.
How are ACIST Medical Systems, Inc.’s devices classified under regulatory frameworks, and what does this mean?
ACIST Medical Systems, Inc.’s devices fall under FDA classifications of Class I, II, IIa, and IIb, which determine the regulatory scrutiny they face. Class I devices (e.g., some accessories) generally pose minimal risk and require basic controls, while Class IIb devices (e.g., advanced imaging systems) involve higher risk and require special controls or performance standards. This classification system ensures appropriate oversight based on the device’s potential impact on patient safety and health outcomes, guiding requirements like premarket submissions or post-market monitoring.
Why might a healthcare provider need to check registries like eudamed or FDA’s UDI database for ACIST devices?
Healthcare providers may verify registries like eudamed or the FDA’s UDI database to confirm a device’s regulatory status, compliance history, and market authorization. For instance, eudamed ensures a device is legally placed on the EU market, while the UDI database provides critical details like batch/lot numbers for traceability in case of recalls or adverse events. This helps providers ensure they are using authorized, up-to-date devices that meet safety and performance standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 7905, Fuller Road, Eden Prairie, United States
- Website
- acist.com/
- facebook.com/ACISTMedicalSystemsInc
- [email protected]
- Phone
- +1 612-227-4734
- PRRC Contact
- Milana Solganik
- EUDAMED SRN
- US-MF-000010784
- FDA FEI Number
- 3001726808
- DUNS Number
- —
Catalogue (274)
Page 2 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| RXi® Cable | 017751 | FDA UDI | Class II | Active |
| CVi® Cable | 015644 | FDA UDI | Class II | Unknown |
| AngioTouch® Kit | 014644 | FDA UDI | Class II | Unknown |
| BT2000 Automated Manifold Kit | 014613 | FDA UDI | Class II | Unknown |
| RXi® Cable | 017688 | FDA UDI | Class II | Active |
| AngioTouch® Kit | 019499 | FDA UDI | Class II | Active |
| RXi® Cable | 018369 | FDA UDI | Class II | Active |
| AngioTouch® Kit | 014644 | FDA UDI | Class II | Unknown |
| AngioTouch® Kit | 014644 | FDA UDI | Class II | Unknown |
| ACIST CVi®1 Contrast Delivery System Injector Head | 016670 | FDA UDI | Class II | Unknown |
| BT2000 Automated Manifold Kit | 014613 | FDA UDI | Class II | Unknown |
| CVi® Cable | 015433 | FDA UDI | Class II | Active |
| RXi® Cable | 017690 | FDA UDI | Class II | Active |
| ACIST CVi® Contrast Delivery System Control Panel | 016227 | FDA UDI | Class II | Active |
| ACIST CVi® Angiographic Injection System Injector Head | 014658 | FDA UDI | Class II | Unknown |
| RXi® Cable | 018367 | FDA UDI | Class II | Active |
| ACIST RXi® System and Accessories | 014666 | FDA UDI | Class II | Unknown |
| ACIST HDi® System Console | 017987 | FDA UDI | Class II | Active |
| ACIST Kodama® Coronary Imaging Catheter | 017788 | FDA UDI | Class II | Active |
| ACIST HDi® Patient Interface Module (PIM) | 017989 | FDA UDI | Class II | Unknown |
| A2000 Multi-use Syringe Kit | 014612 | FDA UDI | Class II | Unknown |
| ACIST RXi® System | 014666 | FDA UDI | Class II | Unknown |
| ACIST Kodama® Coronary Imaging Catheter | 017788 | FDA UDI | Class II | Active |
| RXi® Cable | 018363 | FDA UDI | Class II | Active |
| ACIST RXi® System and Accessories | 014666 | FDA UDI | Class II | Unknown |
| A2000 Multi-use Syringe Kit | 014612 | FDA UDI | Class II | Unknown |
| ACIST Navvus® Catheter | 014667 | FDA UDI | Class II | Unknown |
| CVi® Accessory | 014607 | FDA UDI | Class II | Active |
| ACIST RXi® Mini Processing Unit | 018593 | FDA UDI | Class II | Active |
| CVi® Cable | 014610 | FDA UDI | Class II | Unknown |
| ACIST HDi® HD IVUS System | 017986 | FDA UDI | Class II | Unknown |
| BT2000 Automated Manifold Kit | 014613 | FDA UDI | Class II | Unknown |
| ACIST Navvus® Catheter | 014667 | FDA UDI | Class II | Active |
| ACIST HDi® HD IVUS System | 017986 | FDA UDI | Class II | Unknown |
| CVi® Cable | 0146AO | FDA UDI | Class II | Unknown |
| RXi® Cable | 018366 | FDA UDI | Class II | Active |
| CVi® Cable | 015429 | FDA UDI | Class II | Unknown |
| AngioTouch® Kit | 014644 | FDA UDI | Class II | Unknown |
| Multi-use Syringe Kit | 014113 | FDA UDI | Class II | Unknown |
| BT2000 Automated Manifold Kit | 014613 | FDA UDI | Class II | Unknown |
| CVi® Cable | 015628 | FDA UDI | Class II | Unknown |
| CVi® Bed Mount | 014608 | FDA UDI | Class II | Active |
| ACIST CVi® Angiographic Injection System Injector Head | 014657 | FDA UDI | Class II | Unknown |
| BT2000 Automated Manifold Kit | 014613 | FDA UDI | Class II | Unknown |
| A2000 Multi-use Syringe Kit | 014612 | FDA UDI | Class II | Unknown |
| AngioTouch® Kit | 014644 | FDA UDI | Class II | Active |
| ACIST CVi® Contrast Delivery System | 014657 | FDA UDI | Class II | Active |
| CVi® Cable | 0146DA | FDA UDI | Class II | Active |
| ACIST Navvus® Catheter | 014667 | FDA UDI | Class II | Unknown |
| ACIST RXi® Mini Navvus Interface | 018592 | FDA UDI | Class II | Active |
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FDA Recalls (9)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
ACIST Medical Systems, Inc. has nine recall records listed in the FDA database, initiated between October 2, 2003, and January 22, 2021, all marked as terminated. The reasons cited include issues with inadequate sealing of sterile product packages, potential air ingress in manifold kits, misalignment of injection systems leading to unintended multiple injections, bulges or leaks in high-pressure tubing, syringe fractures, damaged o-rings in catheters, separation of bonded lines in automated manifolds, and breached sterile package seals on a specific kit. Each recall involved specific product lots or models and addressed potential performance or sterility concerns.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 22, 2021 | Z-1161-2021 | — | terminated | Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence. |
| Dec 21, 2015 | Z-0744-2016 | — | terminated | Reports related to ingress of air into the manifold. |
| Mar 15, 2013 | Z-1145-2013 | — | terminated | ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed w |
| May 11, 2009 | Z-1872-2009 | — | terminated | ACIST Medical Systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the ACIST BT2000 Automated Manifold Kit. |
| Nov 10, 2008 | Z-0643-2009 | — | terminated | 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. |
| Jun 6, 2008 | Z-2406-2008 | — | terminated | Some of the sterile package seals of AT P54 AngioTouch Kit were breached. Breached package seals could compromise product sterility, which could potentially lead to patient infection. |
| Oct 3, 2007 | Z-0359-2008 | — | terminated | Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture. |
| May 19, 2004 | Z-1002-04 | — | terminated | Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile. |
| Oct 2, 2003 | Z-0064-04 | — | terminated | Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak. |