Data / Medical devices / United States / Mediview XR
Mediview XR: FDA-registered device maker in Cleveland, OH, United States, 1 510(k) clearance
Mediview XR is registered with the FDA (registration 3016110967) in Cleveland, OH, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016110967
- Address
- 10000 Cedar Ave, STE GCIC2-153, Cleveland, OH, United States, 44106
- Owner or operator
- MediView XR (10081343)
- Roles
- Manufacturer
- First device listed
- April 6, 2021
- Registered through
- 2026
- Brand names listed
- EM Probe Bracket Kit, C1-5, Single, EM Probe Bracket Kit, C1-6, Single, Kit, Aurora FG Mounting Brackets, LT, Kit, Aurora FG Mounting Brackets, RT, MediScout system, OmnifyXR, Registration Marker Kit, Sterile, Single, Triangle Template Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| Table And Attachments, Operating-Room | BWN | 1 | 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 |
|---|---|---|---|---|---|---|
| July 13, 2023 | K223125 | XR90 (XR90-SYS) | LLZ | Substantially Equivalent | Mediview Xr, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of System, Digital Image Communications, Radiological
- All makers of Table And Attachments, Operating-Room
Updated July 13, 2023. 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.