Data / Medical devices / Canada / Fujifilm Visualsonics, Inc.
Fujifilm Visualsonics, Inc.: FDA-registered device maker in TORONTO Ontario, Canada, 2 510(k) clearances
Fujifilm Visualsonics, Inc. is registered with the FDA (registration 3003774756) in TORONTO Ontario, Canada. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 15, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003774756
- Address
- 3080 Yonge ST. Suite 6100, TORONTO Ontario, Canada, M4N 3N1
- Owner or operator
- FUJIFILM CORPORATION (8031568)
- Roles
- Specification developer
- First device listed
- May 5, 2016
- Registered through
- 2026
- Brand names listed
- FUJIFILM SonoSite Vevo MD Imaging System, SonoSite Vevo MD Imaging System, Vevo MD Imaging System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 15, 2019 | K190476 | FUJIFILM Sonosite Vevo MD Imaging System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| April 19, 2016 | K160674 | Fujifilm Sonosite Vevo MD Imaging System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
Updated March 15, 2019. 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.