B-Ultrasound Diagnostic System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- B-Ultrasound Diagnostic System EUDAMEDCONTEC FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- B-Ultrasound Diagnostic System EUDAMEDFDA UDI
- Model / Reference
- CMS600P2 EUDAMEDFDA UDI
- Description
- B-Ultrasound Diagnostic System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945040101161 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450401CMS600P2HG EUDAMED
- Direct Marketing DI
- 06945040101161 EUDAMED
- FDA Product Code
- IYO FDA 510(k)FDA UDIITX FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)FDA UDI892.1570 FDA UDI
- Market of Registration
- Greece EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The B-Ultrasound Diagnostic System is a portable ultrasound imaging device designed for diagnostic radiology applications. It employs ultrasound technology to generate real-time visual images of internal body structures, aiding in the assessment of organs, tissues, and potential pathologies such as tumors, cysts, or vascular conditions.
This system is supplied as a reusable medical device, intended for use in clinical settings such as hospitals, diagnostic centers, or outpatient facilities. It is regulated under FDA 510(k) clearance (K232895) and the EU Medical Device Regulation (MDR), with a classification under the product code IYO. Sterility and MRI safety specifications are not detailed in the provided data, but it is intended for professional medical use by trained operators.
Frequently asked questions
What types of clinical settings is the B-Ultrasound Diagnostic System intended for use in?
The B-Ultrasound Diagnostic System is designed for professional medical use in clinical environments such as hospitals, diagnostic centers, and outpatient facilities. Its portable nature and diagnostic radiology applications make it suitable for settings where real-time imaging of internal structures—like organs, tissues, or vascular conditions—is required.
Is the B-Ultrasound Diagnostic System single-use or reusable, and how does this affect its maintenance?
The B-Ultrasound Diagnostic System is explicitly described as a reusable medical device. This means it is intended for repeated use in clinical settings, requiring proper cleaning, disinfection, and maintenance protocols to ensure reliability and patient safety. Reusability also implies it must be handled by trained personnel following manufacturer guidelines to avoid cross-contamination or damage.
What regulatory pathways does the B-Ultrasound Diagnostic System follow, and how does this impact its use?
The B-Ultrasound Diagnostic System has undergone FDA 510(k) clearance (K232895) and complies with the EU Medical Device Regulation (MDR). The FDA classification under product code IYO (Radiology) and the advisory committee designation (RA) indicate it is intended for diagnostic imaging purposes. These regulatory routes ensure the device meets safety and performance standards for professional medical use by trained operators.
How does the portability of the B-Ultrasound Diagnostic System benefit clinical workflows?
As a portable ultrasound system, the B-Ultrasound Diagnostic System is designed to be easily moved between different clinical areas, such as wards, emergency rooms, or outpatient departments. This portability enhances flexibility in patient care by allowing imaging to be performed at the point of need—whether for bedside assessments, mobile diagnostic services, or situations where transporting patients to a fixed imaging unit is impractical.
What should clinicians consider when storing or transporting the B-Ultrasound Diagnostic System?
While specific storage conditions (e.g., temperature, humidity) aren’t detailed in the provided data, the system’s reusable and portable nature suggests it should be stored in a clean, dry environment protected from physical damage or contamination. Clinicians should follow manufacturer instructions for transport to ensure the device remains operational and safe for use, particularly if moved between different facilities or settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K232895 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- FDA Applicant
- Contec Medical Systems Co.,Ltd
Sources (3)
- FDA 510(k) K232895 24 fields · synced Sep 18, 2026
- FDA UDI e3fe5660-3d7d-4821-b1df-c2b769e111d0 34 fields · synced May 30, 2026
- EUDAMED dad7af7b-cd59-4b62-aac3-ff6fa2f79526 61 fields · synced Jul 19, 2026