Acist Kodama® Coronary Imaging Catheter
The ACIST Kodama Coronary Imaging Catheter works with the ACIST HDi System to obtain ultrasound images from inside blood vessels. Its distal transducer sends sound waves into surrounding…
The ACIST Kodama Coronary Imaging Catheter works with the ACIST HDi System to obtain ultrasound images from inside blood vessels. Its distal transducer sends sound waves into surrounding vascular tissue and receives their echoes. The system reconstructs these signals into real-time cross-sectional images for examination of coronary and peripheral vascular pathology.
The catheter operates at 40 MHz or 60 MHz. A coaxial cable within its drive cable carries signals back to the HDi console for processing and image reconstruction. Intravascular imaging is intended for patients who are candidates for transluminal interventional procedures.
Listed Item
Kodama Catheter, p/n 701470 Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag, IFU
Imaging Assembly
The system’s patient interface module secures the catheter and rotates its imaging assembly. An optional linear translation system mechanically couples to the catheter and interface module to provide controlled automatic pullback; manual pullback is also possible.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Jiangsu Tingsn Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 4 |
| Nanjing Shuangwei Biotechnology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 1 |
Record
| Listed by | Acist Medical Systems, Inc., United States |
|---|---|
| FDA product code | OBJ |
| Device type | Catheter, Ultrasound, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K193183 |
| Record published | 2025-08-14 |
| Record revised | 2024-02-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Shelf box of 5, pack of 5, single pack |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 017788 | In distribution | |
| 017788 | Frequency: 40/60 Mega HertZ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 27 |
| Acist HDi® HD Ivus System | Acist Medical Systems, Inc. | 8 |
| Soundstar | Biosense Webster, Inc. | 6 |
| OptiCross | Boston Scientific Corporation | 4 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 4 |
| Acist HDi® System Console | Acist Medical Systems, Inc. | 4 |
| OptiCross™ 6 | Boston Scientific Corporation | 3 |
| 7 Fr PV-Catheter | CD Leycom | 3 |
| NES Reprocessed Visions PV.014P RX Digital Ivus Catheter | North East Scientific Inc | 3 |
| OptiCross™ 6 HD | Boston Scientific Corporation | 2 |
| Acist HDi® Bed Rail Mount | Acist Medical Systems, Inc. | 2 |
| 4 Fr PV Catheter | CD Leycom | 2 |
Showing 12 of 63. All products under Catheter, Ultrasound, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193183 | 2020-03-20 |
| K191175 | 2019-06-27 |
| K173063 | 2017-10-23 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Acist Medical Systems, Inc. | 510(k) number | 2021-01-22 | Class I | Device Design | 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. AC | 1185 units | 2023-10-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.