Data / Medical devices / United States / Rivanna Medical, Inc
Rivanna Medical, Inc: FDA-registered device maker in Charlottesville, VA, United States, 1 510(k) clearance
Rivanna Medical, Inc is registered with the FDA (registration 3011692238) in Charlottesville, VA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 11, 2014. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011692238
- Address
- 2400 Hunters Way, Charlottesville, VA, United States, 22911
- Owner or operator
- Rivanna Medical (10050090)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 12, 2015
- Registered through
- 2026
- Brand names listed
- Accuro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 11, 2014 | K132736 | ACCURO 3000 ULTRASOUND SCANNER | IYO | Substantially Equivalent | Rivanna Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
Updated March 11, 2014. 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.