Data / Medical devices / United States / Imaging Biometrics, LLC
Imaging Biometrics, LLC: FDA-registered device maker in Elm Grove, WI, United States, 3 510(k) clearances
Imaging Biometrics, LLC is registered with the FDA (registration 3007225492) in Elm Grove, WI, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 29, 2020. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007225492
- Address
- 13416 Watertown Plank Rd Suite 260, Elm Grove, WI, United States, 53122
- Owner or operator
- Imaging Biometrics, LLC (10025928)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- September 6, 2013
- Registered through
- 2026
- Brand names listed
- IB Clinic, IB DCE, IB Delta Suite, IB Diffusion, IB Neuro, IB Rad Tech, LSN, StoneChecker
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 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 |
|---|---|---|---|---|---|---|
| October 29, 2020 | K201092 | LSN | JAK | Substantially Equivalent | Imaging Biometrics, LLC | accessdata.fda.gov |
| September 26, 2019 | K191530 | StoneChecker | LLZ | Substantially Equivalent | Imaging Biometrics, LLC | accessdata.fda.gov |
| January 11, 2013 | K123302 | IB CLINIC | LLZ | Substantially Equivalent | Imaging Biometrics, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of System, X-Ray, Tomography, Computed
Updated October 29, 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.