Master-Vu A-Scan MV4500
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100252 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Master-Vu A-Scan MV4500 is a diagnostic ophthalmic ultrasound system classified as an A-scan biometry device (per FDA nomenclature). It employs ultrasound technology to measure ocular biometric parameters, including axial length, anterior chamber depth, and lens thickness, enabling precise intraocular lens (IOL) power calculations for cataract surgery planning. Designed for non-invasive ocular imaging, it provides quantitative data critical for preoperative assessment and refractive surgery planning.
This portable, reusable device is intended for use in clinical settings such as ophthalmology clinics, surgical centers, or mobile eye care units. Supplied with a compact carrying case for transport, it connects via USB to Windows-based PCs or tablets for data review, storage, and analysis. The system adheres to FDA 510(k) clearance (K100252) and MDD compliance, with no specified sterility requirements as it is not intended for direct patient contact beyond ultrasound probe application. User profiles and scan editing features enhance workflow efficiency.
Frequently asked questions
What clinical measurements does the Master-Vu A-Scan MV4500 provide for cataract surgery planning?
The Master-Vu A-Scan MV4500 measures key ocular biometric parameters such as axial length, anterior chamber depth, and lens thickness. These measurements are essential for calculating intraocular lens (IOL) power, which helps surgeons determine the appropriate lens for cataract patients during preoperative assessment.
Is the Master-Vu A-Scan MV4500 designed for direct patient contact, and if not, what are the sterility requirements?
No, the Master-Vu A-Scan MV4500 is not intended for direct patient contact beyond the application of the ultrasound probe. Since it is a reusable device and does not require sterility for patient contact, no specific sterility requirements are mentioned in its documentation.
How is the Master-Vu A-Scan MV4500 connected to a computer for data analysis, and what operating systems does it support?
The Master-Vu A-Scan MV4500 connects to a computer via USB and is designed to work with Windows-based PCs or tablets. This connectivity allows users to review, store, and analyze scan data efficiently.
What type of clinical settings is the Master-Vu A-Scan MV4500 intended for, and how is it transported?
The Master-Vu A-Scan MV4500 is intended for use in clinical settings like ophthalmology clinics, surgical centers, or mobile eye care units. It is portable and supplied with a compact carrying case, making it easy to transport between locations.
What regulatory pathways has the Master-Vu A-Scan MV4500 followed, and what does this mean for its use?
The Master-Vu A-Scan MV4500 has followed the FDA 510(k) clearance pathway (K100252) and complies with the Medical Device Directive (MDD). This means the device has been reviewed and deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and performance in its intended clinical 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: SONOMED, INC. MV4500 Master-Vu A-Scan Ophthalmic Ultrasound System, Master-Vu Ophthalmic Ultrasound - sonomedescalon, MV4500 Master-Vu A-Scan - Beye, Ophthalmic Ultrasound - Sonomed Escalon
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K100252 | Class II | Active |
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Manufacturer
- Manufacturer
- Sonomed, Inc.
Sources (2)
- FDA 510(k) K100252 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026