Data / Medical devices / Israel / Viasonix Ltd.
Viasonix Ltd.: FDA-registered device maker in RAANANA Central, Israel, 6 510(k) clearances
Viasonix Ltd. is registered with the FDA (registration 3009286597) in RAANANA Central, Israel. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009286597
- Address
- 9 Dafna St., RAANANA Central, Israel, 4366223
- Owner or operator
- VIASONIX LTD (10038161)
- Roles
- Manufacturer
- First device listed
- September 20, 2011
- Registered through
- 2026
- Brand names listed
- Dolphin IQ and Dolphin/4D, Dolphin/IQ, Dolphin/4D and Dolphin/MAX, Dolphin/IQ, Dolphin/4D, Dolphin/Xpress and Dolphin/MAX with Dolphin/XF Robot Accessory, FALCON/PRO, FALCON/QUAD, FALCON/ABI, Falcon/Xpress, LiteWalk
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diagnostic Ultrasonic Transducer, Robotic | OQQ | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic | JOP | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 18, 2024 | K242662 | Falcon/Xpress (Falcon/Xpress) | JOP | Substantially Equivalent | Viasonix , Ltd. | accessdata.fda.gov |
| January 25, 2021 | K202742 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory | IYN | Substantially Equivalent | Viasonix , Ltd. | accessdata.fda.gov |
| December 19, 2019 | K192607 | LiteWalk | IRP | Substantially Equivalent | Viasonix , Ltd. | accessdata.fda.gov |
| May 16, 2019 | K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | IYN | Substantially Equivalent | Viasonix , Ltd. | accessdata.fda.gov |
| November 14, 2017 | K170859 | Dolphin/IQ and Dolphin/4D | IYN | Substantially Equivalent | Viasonix , Ltd. | accessdata.fda.gov |
| July 15, 2011 | K111416 | FALCON | JOP | Substantially Equivalent | Viasonix , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Massager, Powered Inflatable Tube
- All makers of Diagnostic Ultrasonic Transducer, Robotic
Updated December 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.