FDA Registration
Active
🇮🇱 Israel
FALCON/PRO, FALCON/QUAD, FALCON/ABI
Reg #: 3009286597
·
FEI: 3009286597
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Viasonix Ltd.
- Registration Number
- 3009286597
- FEI Number
- 3009286597
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9 Dafna St.
- City
- RAANANA Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K111416
Owner / Operator
- Firm Name
- VIASONIX LTD
- Operator Number
- 10038161
- Address
- 10 Hamelacha Street
- City
- Raanana
- State
- IL-NOTA
- Postal Code
- 43661
- Country
- IL
- Correspondent
- Dan Manor
US Agent
- Business Name
- Image Monitoring USA Inc.
- Contact Name
- Tanya Tomlinson
- Address
- 173 Dingens St.
- City
- Buffalo
- State
- NY
- ZIP
- 14206
- Country
- US
- [email protected]
- Phone
- 716 8533703
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic | JOP | Class 2 | Cardiovascular | No | 2011-09-20 |
Proprietary Names
FALCON/PRO, FALCON/QUAD, FALCON/ABI
Establishment Types
Manufacture Medical Device