Identity
- Trade Name
- Dolphin/XF Robot Accessory FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity FDA UDI
- Model / Reference
- Dolphin/XF Robot Accessory FDA UDI
- Description
- The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016880229 FDA UDI
- 510(k) Number
- K202742 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDIOQQ FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1570 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
Dolphin/XF Robot Accessory 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 d9e0e5ac-7e52-4246-a2e6-ff04c2d57cab 35 fields · synced May 29, 2026