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Falcon/Quad
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref PVC0078Model Falcon – Vascular diagnostic systems
Identity
- Trade Name
- Falcon/Quad EUDAMEDFalcon FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Falcon/Pro EUDAMEDintended for use in the noninvasive evaluation of peripheral vascular pathology in patients FDA UDI
- Model / Reference
- Falcon – Vascular diagnostic systems EUDAMEDPVC0078 EUDAMEDQuad FDA UDI
- Description
- intended for use in the noninvasive evaluation of peripheral vascular pathology in patients FDA UDI
Identifiers
- Catalog Number
- PVC0078 FDA UDI
- Primary DI / UDI-DI
- 07290016880014 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001688033CG EUDAMED
- 510(k) Number
- K111416 FDA UDI
- FDA Product Code
- JOP FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2880 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Falcon/Quad by Viasonix Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111416 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 729001688033CG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Viasonix Ltd.
- EUDAMED SRN
- IL-MF-000021015
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (3)
- EUDAMED d02a1efc-163a-41d8-bb32-3f4082251b07 61 fields · synced Jul 10, 2026
- FDA UDI f5ae45fe-14b9-44d8-a5cf-def69ba9b7fd 35 fields · synced May 29, 2026
- FDA 510(k) K111416 1 fields · synced May 18, 2026