Dc-8/ Dc-8 Pro/ Dc-8 Cv/ Dc-8 Exp/ Dc-8s Diagnostic Ultrasound Systems
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132341 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DC-8 series is a family of diagnostic ultrasound systems designed for medical imaging. These devices use high-frequency sound waves to generate real-time visual images of internal body structures, aiding in the diagnosis of conditions across multiple specialties, including obstetrics, cardiology, and general radiology.
The systems are supplied as reusable medical equipment, intended for use in clinical, hospital, or diagnostic imaging settings. They are not described as sterile or single-use and must comply with MRI safety standards as applicable. Each model (DC-8, DC-8 PRO, DC-8 CV, DC-8 EXP, DC-8S) may vary in specifications, but all share the same product code (IYN) under FDA 510(k) clearance (K132341) and EU MDR authorization. Storage and maintenance follow manufacturer guidelines outlined in accompanying service manuals.
Frequently asked questions
Are these ultrasound systems intended for single-use or can they be reused in a clinical setting?
The DC-8 series diagnostic ultrasound systems are designed as reusable medical equipment, not for single-use. They are meant for repeated use in clinical, hospital, or diagnostic imaging environments, with maintenance and cleaning following the manufacturer’s guidelines provided in the service manuals.
What types of imaging specialties can these systems support, and how does that translate to clinical use?
The DC-8 series is engineered for multi-specialty diagnostic imaging, including obstetrics, cardiology, and general radiology. This versatility allows clinicians to visualize internal structures in real-time using high-frequency sound waves, aiding in the diagnosis of conditions across these fields without requiring separate devices for each specialty.
How do I ensure these systems comply with MRI safety standards if they’re used in facilities with MRI equipment?
While the DC-8 series itself isn’t explicitly labeled as MRI-compatible, the manufacturer states these systems must comply with MRI safety standards as applicable. This implies they should be used in accordance with the facility’s MRI safety protocols, including proper shielding, labeling, and adherence to guidelines to prevent interference or hazards in MRI environments.
Are there differences between the DC-8 models (e.g., DC-8 PRO vs. DC-8 CV), and how might that affect my purchase decision?
Each model in the DC-8 series (DC-8, DC-8 PRO, DC-8 CV, DC-8 EXP, DC-8S) may vary in specifications, though the exact differences aren’t detailed here. The key factor for buyers is that all share the same FDA 510(k) clearance (K132341) and EU MDR authorization, ensuring regulatory consistency. To determine which model best fits your needs, consult the manufacturer’s documentation or a sales representative, as variations likely cater to specific workflows (e.g., cardiovascular vs. general imaging).
What regulatory pathways have these ultrasound systems undergone, and how does that affect their use in the U.S. and EU?
The DC-8 series has undergone FDA 510(k) clearance (K132341) under the Traditional pathway, deemed *Substantially Equivalent* to a predicate device, and EU MDR authorization. In the U.S., this clearance allows for commercial distribution and use in clinical settings as intended for diagnostic imaging. In the EU, MDR authorization ensures compliance with current medical device regulations, enabling legal market placement and use under the applicable clinical guidelines.
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. Sources consulted: Mindray DC-8 PRO, DC-8 CV, DC-8 EXP, DC-8S Service Manual (Advanced ..., Mindray DC-8 PRO, CV, EXP, S Ultrasound System Service Manual, MINDRAY DC-8 SERVICE MANUAL Pdf Download | ManualsLib, PDF DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System ...
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 | K132341 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K132341 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 25, 2026