Identity
- Trade Name
- A Standardized Probe FDA UDI
- Generic Name
- Ophthalmic ultrasound imaging transducer FDA UDI
- Device Name
- Digitally programmed S-shaped amplifier characteristics and comprehensive design criteria for standardized echography and tissue differentiation according to Karl C. Ossoinig MD FDA UDI
- Model / Reference
- Std-A FDA UDI
- Description
- Digitally programmed S-shaped amplifier characteristics and comprehensive design criteria for standardized echography and tissue differentiation according to Karl C. Ossoinig MD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700542625118 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
A Standardized Probe by Quantel Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quantel Medical
Sources (1)
- FDA UDI be65911d-7508-4d40-bb42-59b12d144ad1 35 fields · synced Jun 8, 2026