Soundstar Crystal Ultrasound Catheter
Soundstar Crystal is a steerable ultrasound catheter for viewing cardiac and great-vessel anatomy from inside the heart or vessel. Its imaging plane is located at the catheter tip, which…
Soundstar Crystal is a steerable ultrasound catheter for viewing cardiac and great-vessel anatomy from inside the heart or vessel. Its imaging plane is located at the catheter tip, which the physician maneuvers to view the region of interest.
The catheter connects to a compatible ultrasound system for real-time imaging. When used with a compatible CARTO 3 electrophysiology navigation system, it also supplies location information and integrates ultrasound images with the navigation display.
System Compatibility
The catheter can visualize both anatomy and other devices within the heart. Its ultrasound and navigation connections depend on the specific compatible system version; compatibility with an earlier CARTO 3 version is not automatic. The catheter is disposable and intended for single use.
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 | Biosense Webster, Inc., United States |
|---|---|
| FDA product code | OBJ |
| Device type | Catheter, Ultrasound, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K240050 |
| Record published | 2024-06-26 |
| Record revised | 2025-03-07 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Storage | Storage environment humidity 0 to 90 % RH; Storage environment temperature 5 to 25 °C; Storage environment temperature 41 to 77 °F; Special storage condition: Do not use if package is opened; Special storage condition: Keep away from sunlight; Special storage condition: Keep dry |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11510826 | 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 |
|---|---|
| K241540 | 2024-06-28 |
| K240050 | 2024-06-12 |
| K223766 | 2023-02-16 |
| K140318 | 2014-03-12 |
| K112050 | 2011-11-18 |
| K101138 | 2010-06-22 |
| K091352 | 2009-12-04 |
| K092064 | 2009-08-07 |
| K070242 | 2007-05-15 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-09-10 | Class II | Device Design | Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when us | 1035 (U.S.) | 2016-05-13 |
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.