7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253310 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
- Models / Variants
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 7600 Ultrasound System (MyLabC25; MyLabC30) is a portable diagnostic imaging device classified as a System, Imaging, Pulsed Doppler, Ultrasonic under FDA nomenclature. It generates high-resolution ultrasound images and Doppler signals to evaluate tissue structure, blood flow, and organ function in real time, supporting radiology and clinical assessments.
This system is designed for portable use in clinical settings, maintaining the core imaging capabilities of its predecessor while incorporating a modified physical design for mobility. Supplied as a reusable device, it adheres to FDA 510(k) clearance (K253310) and MDR compliance, intended for radiology applications. No specific sterility or MRI safety classifications are stated in the provided data.
Frequently asked questions
What clinical applications does the 7600 Ultrasound System (MyLabC25/MyLabC30) primarily support based on its design and FDA classification?
The 7600 Ultrasound System (MyLabC25/MyLabC30) is classified under FDA nomenclature as a *System, Imaging, Pulsed Doppler, Ultrasonic* with a product code of IYN (Radiology). This classification indicates its primary use for generating high-resolution ultrasound images and Doppler signals to assess tissue structure, blood flow, and organ function in real-time. Clinically, this supports radiology and general clinical evaluations, such as vascular studies, obstetrics, abdominal scans, and musculoskeletal assessments, where portable imaging is advantageous.
Is the 7600 Ultrasound System designed for single-use or reusable applications, and what does this mean for maintenance?
The 7600 Ultrasound System is explicitly described as a *reusable device*, meaning it is not intended for single-use. This implies that the system requires routine cleaning, disinfection, and maintenance to ensure proper functionality and infection control between uses in clinical settings. Reusability also suggests it may need periodic servicing or part replacements to maintain performance over time.
How does the portability of the 7600 Ultrasound System differ from its predecessor, and what practical benefits does this offer?
The 7600 Ultrasound System is designed with a *modified physical design for mobility*, distinguishing it from its predecessor by being explicitly labeled as portable. This means it is built to be easily transported between clinical areas (e.g., wards, emergency rooms, or outpatient settings) without sacrificing core imaging capabilities like high-resolution ultrasound and Doppler functionality. The portability reduces the need for patients to be moved to a fixed imaging suite, improving accessibility and convenience for both clinicians and patients.
What regulatory pathways does the 7600 Ultrasound System follow, and what does this imply for its use in the U.S.?
The system follows the FDA 510(k) clearance pathway under the classification *Special* (decision code SESE) and is determined *Substantially Equivalent* to a predicate device. This means it has undergone FDA review to confirm it meets safety and effectiveness standards for its intended radiology applications. Clinically, this implies the device has been evaluated for compliance with U.S. regulations, ensuring it can be legally marketed and used in diagnostic imaging settings under FDA oversight.
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: 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30 ..., 7600 Ultrasound System (MyLabC25); 7600 Ultrasound… - FDA.report, The new portable ultrasound system MyLab™C25 - Esaote
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 | K253310 | Class II | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- FDA Applicant
- Esaote, S.p.A.
Sources (2)
- FDA 510(k) K253310 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026