Identity
- Trade Name
- VuMAX EUDAMEDVuMAX HD Ophthalmic Ultrasound System FDA UDI
- Generic Name
- Ophthalmic ultrasound imaging system FDA UDI
- Device Name
- VuMAX Ophthalmic Ultrasound EUDAMEDThe VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microscope (UBM) device for imaging ocular features for diagnostic purposes. It combines both A-scan and B-scan modes ultilizing a 35 MHz and/or 50 MHz transducer with a sector scanning probe and operates on a computer-based platform. The A-scan measures axial length (AXL), anterior chamber depth, lens thickness and vitreous length. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. UBM capabilities include sulcus-to-sulcus, angle detail, high resolution, and motion picture settings. The system includes the multi-frequency ultrasound system base unit, 22" LCD, water-path probe with 35 MHz transducer, 12 MHz B-probe, 10 mHz A-probe, keyboard and mouse, USB foot switch, immersion cups and user manual. FDA UDI
- Model / Reference
- VuMAX BUA EUDAMEDBUA.575 EUDAMEDVuMAX HD A/B/UBM FDA UDI
- Description
- The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microscope (UBM) device for imaging ocular features for diagnostic purposes. It combines both A-scan and B-scan modes ultilizing a 35 MHz and/or 50 MHz transducer with a sector scanning probe and operates on a computer-based platform. The A-scan measures axial length (AXL), anterior chamber depth, lens thickness and vitreous length. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. UBM capabilities include sulcus-to-sulcus, angle detail, high resolution, and motion picture settings. The system includes the multi-frequency ultrasound system base unit, 22" LCD, water-path probe with 35 MHz transducer, 12 MHz B-probe, 10 mHz A-probe, keyboard and mouse, USB foot switch, immersion cups and user manual. FDA UDI
Identifiers
- Catalog Number
- BUA.575 FDA UDI
- Primary DI / UDI-DI
- 00896100002217 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00896100002217 EUDAMED
- 510(k) Number
- K060626 FDA UDI
- FDA Product Code
- IYO FDA UDI
- EMDN Code
- Z11040199 ULTRASOUND SCANNERS - OTHER EUDAMED
- GMDN Term
- Ophthalmic ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
VuMAX by Sonomed, Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060626 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00896100002217 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sonomed, Inc.
- EUDAMED SRN
- US-MF-000002342
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 20fff436-dcfc-4b40-95f5-d476a80ab05e 61 fields · synced Aug 1, 2026
- FDA UDI aa6437fc-3867-4f2b-baa9-fdcf42bf6ebe 36 fields · synced May 25, 2026
- FDA 510(k) K060626 1 fields · synced May 18, 2026