Identity
- Trade Name
- B Probe 20MHz AVISO FDA UDI
- Generic Name
- Ophthalmic ultrasound imaging transducer FDA UDI
- Model / Reference
- B-HF AVISO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700542625064 FDA UDI
- 510(k) Number
- K051851 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Ophthalmic ultrasound imaging transducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic ultrasound imaging transducer
B Probe 20MHz AVISO by Quantel Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic ultrasound imaging transducer.
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- UBM 35 MHz Transducer — DGH Technology, Inc. · Class II
- UBM Probe — DGH Technology, Inc. · Class II
- UBM 50 MHz Transducer — DGH Technology, Inc. · Class II
Cleared under the same submission
K051851 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Quantel Medical
Sources (1)
- FDA UDI 08bbca84-3f90-4ab8-ad70-98258338a245 34 fields · synced May 30, 2026