Data / Medical devices / United States / Genesis Software Innovations
Genesis Software Innovations: FDA-registered device maker in Grand Rapids, MI, United States, 1 510(k) clearance
Genesis Software Innovations is registered with the FDA (registration 3019541896) in Grand Rapids, MI, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 21, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019541896
- Address
- 2851 Charlevoix Dr. SE Suite 327, Grand Rapids, MI, United States, 49546
- Owner or operator
- Genesis Software Innovations (10082110)
- Roles
- Manufacturer
- First device listed
- June 16, 2021
- Registered through
- 2026
- Brand names listed
- Preview Shoulder
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | 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 |
|---|---|---|---|---|---|---|
| April 21, 2021 | K210556 | Preview Shoulder | QIH | Substantially Equivalent | Genesis Software Innovations | accessdata.fda.gov |
Compare with other makers
Updated April 21, 2021. 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.