Data / Medical devices / United States / Isono Health Inc.
Isono Health Inc.: FDA-registered device maker in Sunnyvale, CA, United States, 1 510(k) clearance
Isono Health Inc. is registered with the FDA (registration 3042585081) in Sunnyvale, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 22, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3042585081
- Address
- 538 Oakmead Pkwy, Sunnyvale, CA, United States, 94085
- Owner or operator
- iSono Health Inc. (10095119)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 26, 2026
- Registered through
- 2026
- Brand names listed
- ATUSA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| April 22, 2022 | K213620 | ATUSA Automated 3D Breast Ultrasound System | IYO | Substantially Equivalent | Isono Health, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
Updated April 22, 2022. 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.