Identity
- Trade Name
- 4 MHz probe FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- 4 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the Dolphin system for noninvasive measurements of blood flow velocities in arteries and veins FDA UDI
- Model / Reference
- 4 MHz probe FDA UDI
- Description
- 4 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the Dolphin system for noninvasive measurements of blood flow velocities in arteries and veins FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016880052 FDA UDI
- 510(k) Number
- K170859 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
4 MHz probe by Viasonix Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Viasonix Ltd
Sources (1)
- FDA UDI f613aeb4-c794-44ce-a55d-1abca7b357ba 35 fields · synced Jun 8, 2026