CBit Series Digital Color Doppler Ultrasound System
by CHISON Medical Technologies Co., Ltd. EUDAMED510(k)GUDID
Active
510(k) K180974Ref QBit 5
Overview
The CBit Series Digital Color Doppler Ultrasound System is a diagnostic imaging device classified as a Digital Color Doppler Ultrasound System under the FDA’s product code IYN. It combines real-time ultrasound imaging with color Doppler functionality to visualize blood flow within vessels and organs, aiding in the assessment of vascular conditions, organ perfusion, and other circulatory evaluations. The system is designed for radiologic applications, providing detailed visualization of soft tissues and fluid dynamics through high-resolution imaging and Doppler analysis.
This cart-based system is intended for use in clinical, hospital, or diagnostic imaging settings and is supplied as a reusable medical device. The CBit Series operates under FDA 510K clearance and MDR compliance, ensuring adherence to regulatory standards for safety and performance. Models within the series include specific configurations (e.g., CBit 8, CBit 9) with varying technical specifications, such as screen size (e.g., 21.5-inch displays) and transducer capabilities. Storage and maintenance follow manufacturer guidelines to preserve functionality and sterility where applicable, though the device itself is not single-use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69451214QBitWY | Date18 Mar 2026 | StatusActive |
| United States | FDA 510(k)SESE 510(k) | NumberK180974 | Date17 Aug 2018 | StatusActive |
| United States | GUDID listing GUDID | Number06945121403221 | Date24 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- QBit Series Diagnostic Ultrasound System
- Generic Name
- General-purpose ultrasound imaging system
- Model / Reference
- QBit 5
- Primary DI / UDI-DI
- 06945121403221
- Basic UDI-DI
- 69451214QBitWY
- FDA Product Code
- IYN
- EMDN Code
- Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
- GMDN Term
- General-purpose ultrasound imaging system
- Device Class
- Class IIa EUDAMEDClass II 510(k)GUDID
- Regulation
- 21 CFR Part 892.1550
- Market of Registration
- Italy
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | 510(k) | GUDID |
|---|---|---|---|
| 510(k) Number | n/a | K180974 | K150861 |
| Device Class | Class IIa | Class II | Class II |
Other devices from CHISON Medical Technologies Co., Ltd.
See all devices from CHISON Medical Technologies Co., Ltd. →
Questions
What clinical applications is the CBit Series Digital Color Doppler Ultrasound System primarily used for?
The CBit Series is designed for radiologic applications to visualize blood flow and organ perfusion using real-time ultrasound imaging combined with color Doppler technology. Clinicians use it to assess vascular conditions, evaluate soft tissue structures, and analyze fluid dynamics within vessels and organs, helping in the diagnosis of circulatory issues and organ health.
Is the CBit Series Digital Color Doppler Ultrasound System single-use or reusable, and how should it be maintained?
The CBit Series is a reusable medical device, not single-use. Maintenance and storage follow the manufacturer’s guidelines to ensure proper functionality and longevity. While the device itself isn’t sterile for repeated patient use, its components may require cleaning and servicing as specified by CHISON Medical Technologies to maintain performance.
What are the key differences between the CBit 8 and CBit 9 models in terms of display and functionality?
The CBit Series includes models like the CBit 8 and CBit 9, which differ primarily in technical specifications such as screen size (e.g., 21.5-inch displays) and transducer capabilities. While exact specifications aren’t detailed here, these variations allow for tailored imaging needs depending on clinical requirements, such as resolution or ergonomic preferences.
How is the CBit Series Digital Color Doppler Ultrasound System regulated, and what does that mean for buyers?
The CBit Series holds both FDA 510K clearance and MDR compliance, meaning it meets regulatory standards for safety and performance in the U.S. and European markets. Buyers can rely on this approval to ensure the device adheres to established guidelines for diagnostic imaging devices, though specific regional requirements should still be verified before purchase.
What type of settings is the CBit Series Digital Color Doppler Ultrasound System intended for, and how is it supplied?
The CBit Series is designed for clinical, hospital, or diagnostic imaging settings where detailed vascular and organ assessments are required. It is supplied as a cart-based system, making it suitable for permanent installation in radiology departments or imaging centers, rather than as a portable or disposable device.
Properties
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No