Data / Medical devices / United States / Resoundant, Inc.
Resoundant, Inc.: FDA-registered device maker in Rochester, MN, United States, 2 510(k) clearances
Resoundant, Inc. is registered with the FDA (registration 3013695852) in Rochester, MN, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 10, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013695852
- Address
- 421 1st Ave SW STE 204W, Rochester, MN, United States, 55902
- Owner or operator
- Resoundant, Inc. (10054926)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 14, 2017
- Registered through
- 2027
- Brand names listed
- Hepatogram Plus, MR Elastography System, Resoundant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Test-Pattern, Radiographic | IXF | 1 | 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 |
|---|---|---|---|---|---|---|
| July 10, 2020 | K201389 | Resoundant Acoustic Driver System | LNH | Substantially Equivalent | Resoundant, Inc. | accessdata.fda.gov |
| August 1, 2019 | K183193 | MREplus+ Software | LLZ | Substantially Equivalent | Resoundant, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of System, Image Processing, Radiological
- All makers of Test-Pattern, Radiographic
Updated July 10, 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.