Identity
- Trade Name
- 8 MHz probe FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- 8 MHz probe is an ultrasonic transducer that generates acoustic signals and also detects returned signals, intended to be used in combination with the Falcon system for noninvasive peripheral vascular measurements. FDA UDI
- Model / Reference
- 8 MHz probe FDA UDI
- Description
- 8 MHz probe is an ultrasonic transducer that generates acoustic signals and also detects returned signals, intended to be used in combination with the Falcon system for noninvasive peripheral vascular measurements. FDA UDI
Identifiers
- Catalog Number
- PVC0331 FDA UDI
- Primary DI / UDI-DI
- 07290016880403 FDA UDI
- 510(k) Number
- K111416 FDA UDI
- FDA Product Code
- JOP FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2880 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
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
Category: General-purpose ultrasound imaging system
8 MHz probe by Viasonix Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K111416 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
- Viasonix Ltd
Sources (1)
- FDA UDI 3da57f7b-a19d-41c7-8a80-b884b3482392 36 fields · synced Jun 1, 2026