6600 Ultrasound System - 6600 Ultrasound System (MyLabA50)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243253 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
- Models / Variants
- 6600 Ultrasound System (MyLabA50) FDA 510(k)EUDAMED
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 6600 Ultrasound System (MyLabA50 and MyLabA70) is a diagnostic ultrasound device designed for imaging internal body structures using high-frequency sound waves. It provides real-time visualisation of organs, tissues, and blood flow, supporting clinical assessments in radiology and general diagnostic procedures.
These systems are intended for use in clinical settings, including hospitals and diagnostic centres, and are supplied as reusable medical equipment. They comply with FDA 510K and MDR authorisations, ensuring adherence to regulatory standards for safety and performance. The MyLabA50 and MyLabA70 models are classified under product code IYN and are intended for professional medical use by trained operators.
Frequently asked questions
What clinical settings and procedures is the 6600 Ultrasound System primarily designed for, and who operates it?
The 6600 Ultrasound System (MyLabA50 and MyLabA70) is designed for use in clinical settings like hospitals and diagnostic centers. It supports radiology and general diagnostic procedures by providing real-time imaging of internal body structures, organs, tissues, and blood flow. The device is intended for professional medical use and must be operated by trained personnel.
Are the MyLabA50 and MyLabA70 models reusable or single-use, and how does this affect their maintenance?
The 6600 Ultrasound System (MyLabA50 and MyLabA70) is explicitly supplied as reusable medical equipment. This means it is designed for repeated use in clinical environments, requiring proper cleaning, disinfection, and maintenance protocols to ensure safety, performance, and compliance with regulatory standards.
What regulatory pathways have the MyLabA50 and MyLabA70 models followed, and what does this mean for compliance?
The 6600 Ultrasound System (MyLabA50 and MyLabA70) has undergone FDA 510K clearance and complies with the Medical Device Regulation (MDR). This ensures the device meets U.S. and EU safety, performance, and regulatory standards. The classification under product code IYN (Radiology) further confirms its intended use in diagnostic imaging procedures.
How do the MyLabA50 and MyLabA70 models differ in terms of their intended use or capabilities?
While both the MyLabA50 and MyLabA70 are part of the 6600 Ultrasound System series, their specifications are not detailed in the provided data. However, they share the same regulatory pathway (FDA 510K and MDR) and are both classified under product code IYN for radiology use. Differences, if any, would likely lie in performance metrics, features, or technical capabilities not explicitly mentioned here, such as screen size, probe options, or advanced imaging modes.
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 | K243253 | Class II | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- FDA Applicant
- Esaote, S.p.A.
Sources (2)
- FDA 510(k) K243253 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026