Model note · IVUS
ACIST Kodama HD-IVUS catheter
ACIST's HDi system and Kodama catheter make up a rotational high definition IVUS platform. A spinning transducer at the catheter tip can run at 40 or 60 MHz to give cross sectional images of coronary and peripheral vessels. The system has a console, a handheld patient interface module (PIM) that spins the imaging core, and an optional linear translation system for automated pullback. It images by mechanical rotation rather than with a solid state array.
The model
Maker, model and type.
- Maker
- ACIST Medical Systems, Inc.
- Model
- ACIST Kodama HD-IVUS catheter with ACIST HDi System
- Device type
- IVUS
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Imaging frequencies | 40 MHz (standard definition) and/or 60 MHz (high definition) | Source |
| Field of view | 6, 8 and 10 mm, extended in 2020 to 12, 16 and 20 mm; the system picks the highest definition available for the chosen field | Source |
| Pullback and frame rate examples | 1.0 mm/s at 30 frames/s and 10.0 mm/s at 60 frames/s were tested at 20 mm field of view | Source |
| System components | Console with touchscreen, handheld PIM, optional linear translation system (LTS), Kodama catheter | Source |
| Signal path | Coaxial cable embedded in the drive cable carries signals from the transducer back to the console | Source |
| FDA classification and clearances | IYO (21 CFR 892.1560) and OBJ (21 CFR 870.1200), Class II; K173063 (2017), K191175 (2019), K193183 (decided 20 March 2020) | Source |
Recalls
Known FDA recalls.
- Z-1161-20212021-01-22
Damaged o-ring fragments over 200 microns could be flushed out of Kodama catheters; affected lots removed.
FDA record
Sources
Where this note comes from.
- FDA 510(k) K193183 summary, ACIST HDi System and Kodama catheter
- openFDA recall search, ACIST Medical Systems
- openFDA MAUDE problem counts, brand Kodama
Not covered: No ACIST product page, catheter IFU or HDi operator manual was opened, so catheter size, length, guide catheter compatibility and system error messages are not included and manufacturerUrl points to the FDA summary. The installed base is smaller than Philips' and MAUDE holds only about a dozen Kodama reports. ACIST's other recalls concern contrast injectors and are excluded. Recall text was read through openFDA because FDA recall pages returned errors at drafting time.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.