6400 Ultrasound System (MyLabX6, MyLabX7)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190989 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 6400 Ultrasound System (MyLabX6, MyLabX7) is a diagnostic ultrasound device designed for imaging internal body structures using high-frequency sound waves. It falls under the category of radiologic diagnostic imaging equipment, providing real-time visualization for clinical assessment and procedural guidance in various medical specialties, including radiology, obstetrics, cardiology, and vascular studies.
This system is supplied as a reusable medical device, intended for use in clinical, hospital, or outpatient settings. It operates under FDA 510(k) clearance (K190989) and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The device is not labeled as single-use and requires proper maintenance, calibration, and storage as per manufacturer guidelines to ensure performance and sterility. No specific MRI safety classification is stated in the provided data.
Frequently asked questions
Is the 6400 Ultrasound System (MyLabX6, MyLabX7) designed for single-use or can it be reused in a clinical setting?
The 6400 Ultrasound System (MyLabX6, MyLabX7) is explicitly labeled as a reusable medical device. It requires proper maintenance, calibration, and storage to ensure performance and sterility over multiple uses, as outlined by the manufacturer’s guidelines. Since it is not classified as single-use, it is intended for repeated use in clinical, hospital, or outpatient environments.
What types of medical specialties can benefit from using the 6400 Ultrasound System (MyLabX6, MyLabX7) for imaging and procedural guidance?
The system is designed for real-time visualization of internal body structures and is particularly useful in specialties like radiology, obstetrics, cardiology, and vascular studies. Its versatility makes it suitable for diagnostic assessments and procedural guidance across these fields, though the exact clinical applications are determined by the user’s expertise and institutional protocols.
How is the regulatory status of the 6400 Ultrasound System (MyLabX6, MyLabX7) defined, and what does this mean for its use?
The device holds FDA 510(k) clearance (K190989) under a Special 510(k) classification, meaning it was determined to be substantially equivalent to a legally marketed predicate device. It also complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in Europe. This regulatory pathway confirms its safety and effectiveness for diagnostic imaging in approved settings, but it does not imply any specific clinical indication—only that it meets regulatory standards for use.
Does the 6400 Ultrasound System (MyLabX6, MyLabX7) require any special handling or storage conditions to maintain its performance?
While the provided data does not specify exact storage conditions, the system is not single-use and must be maintained according to manufacturer guidelines to ensure performance and sterility. This includes regular calibration, cleaning, and proper storage to prevent contamination or degradation, particularly in clinical or hospital environments where reuse is intended.
What is the significance of the product code IYN and advisory committee designation RA for this device?
The product code IYN categorizes this device under radiologic diagnostic imaging equipment for regulatory filing purposes, while the advisory committee designation RA (Radiology) indicates it was reviewed by the FDA’s Radiological Health Advisory Committee. These codes reflect how the submission was classified and processed administratively, not the device’s clinical function or intended use.
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: Sony Alpha 6400 ab 559,99 € (September 2026 Preise) - idealo, SONY Alpha 6400 Kit Systemkamera mit Objektiv 18-135 mm, 7
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K190989 | Class II | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- FDA Applicant
- Esaote, S.p.A.
Sources (2)
- FDA 510(k) K190989 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026