Data / Medical devices / United States / Sonivate Medical, Inc.
Sonivate Medical, Inc.: FDA-registered device maker in Portland, OR, United States, 1 510(k) clearance
Sonivate Medical, Inc. is registered with the FDA (registration 3009565060) in Portland, OR, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 25, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009565060
- Address
- 4640 S Macadam Ave Ste 200, Portland, OR, United States, 97239
- Owner or operator
- Sonivate Medical, Inc. (10040499)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 19, 2020
- Registered through
- 2026
- Brand names listed
- SonicEye® Dual-Array Ultrasound System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| February 25, 2020 | K192253 | SonicEye Dual-Array Ultrasound System | IYO | Substantially Equivalent | Sonivate Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated February 25, 2020. 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.