Color Doppler Ultrasound Diagnostic System CMS1700B, CMS1700C
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Color Doppler Ultrasound Diagnostic System EUDAMEDCONTEC FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Color Doppler Ultrasound Diagnostic System EUDAMEDFDA UDI
- Model / Reference
- CMS1700B EUDAMEDFDA UDICMS1700B, CMS1700C EUDAMED
- Description
- Color Doppler Ultrasound Diagnostic System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945040106593 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450401CMS1700DT EUDAMED
- Direct Marketing DI
- 06945040106593 EUDAMED
- 510(k) Number
- FDA Product Code
- IYN FDA 510(k)FDA UDIIYO FDA UDIITX FDA UDI
- EMDN Code
- Z11040105 OBSTETRIC/GYNAECOLOGICAL 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 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)FDA UDI892.1560 FDA UDI892.1570 FDA UDI
- Market of Registration
- Romania 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
No
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 Color Doppler Ultrasound Diagnostic System CMS1700B and CMS1700C are portable, high-resolution ultrasound devices designed for real-time imaging and blood flow assessment using color Doppler technology. These systems enable clinicians to visualize internal body structures and evaluate vascular flow, aiding in the diagnosis of cardiovascular conditions, organ pathology, and other medical assessments.
These systems are supplied as reusable medical devices, intended for use in clinical, hospital, or diagnostic imaging settings. They are regulated under FDA 510(k) clearance and EU MDR compliance, with models CMS1700B and CMS1700C distinguished by their technical specifications. Storage and handling follow standard medical equipment protocols to ensure operational integrity and patient safety.
Frequently asked questions
Are these Color Doppler Ultrasound Systems designed for single-use or reusable in clinical settings? Why does this matter?
These systems (CMS1700B and CMS1700C) are explicitly labeled as reusable medical devices, meaning they are built for repeated use in clinical, hospital, or diagnostic settings. This matters because reusable equipment requires proper cleaning, disinfection, and maintenance protocols to ensure patient safety and device longevity, unlike single-use devices which are discarded after one procedure.
What distinguishes the CMS1700B from the CMS1700C, and how might this affect my purchase decision?
The key difference lies in their technical specifications, though the exact distinctions aren’t detailed in the provided data. Both models are FDA 510(k)-cleared and EU MDR-compliant, but variations in performance (e.g., resolution, probe options, or software features) may influence usability for specific diagnostic needs. If your workflow prioritizes particular imaging capabilities, you may need to consult Contec’s technical documentation or a representative to confirm which model aligns best with your requirements.
How should these devices be stored to maintain their functionality and compliance with regulatory standards?
The data specifies that storage and handling follow standard medical equipment protocols, which typically include protecting the devices from physical damage, extreme temperatures, and contamination. Since they are reusable, proper maintenance (e.g., calibration, cleaning, and storage in a controlled environment) is critical to ensure compliance with FDA 510(k) and EU MDR requirements, as well as to preserve imaging accuracy and patient safety over time.
What types of medical assessments or conditions can these Color Doppler Ultrasound Systems help diagnose?
These systems are designed for real-time imaging and blood flow assessment using color Doppler technology, enabling visualization of internal structures and vascular flow. Clinically, this aids in diagnosing cardiovascular conditions, organ pathology, and other medical assessments, though the exact indications aren’t specified beyond this general purpose. The Radiology Advisory Committee (RA) review suggests their primary use aligns with vascular and soft-tissue evaluations, but specific clinical applications should be confirmed with Contec’s documentation or a radiologist.
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 | K232908 | Class II | Active |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- FDA Applicant
- Contec Medical Systems Co.,Ltd
Sources (3)
- FDA 510(k) K232908 24 fields · synced Sep 18, 2026
- FDA UDI 1881d8f3-11ec-4dc9-b77c-24db40c5525d 34 fields · synced May 30, 2026
- EUDAMED 16525565-e0dd-43c8-ae28-8bdbd4b5417b 61 fields · synced Jul 29, 2026