Data / Medical devices / United States / C4 Imaging LLC
C4 Imaging LLC: FDA-registered device maker in Bellaire, TX, United States, 4 510(k) clearances
C4 Imaging LLC is registered with the FDA (registration 3010813819) in Bellaire, TX, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 21, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010813819
- Address
- 6575 West Loop South, Suite 500, Bellaire, TX, United States, 77401
- Owner or operator
- C4 Imaging LLC (10046576)
- Roles
- Specification developer
- First device listed
- April 9, 2014
- Registered through
- 2026
- Brand names listed
- C4 Fiducial Marker, HDR MRI Lumen Marker, MRI Marker, Sirius MRI Marker, Sirius MRI Marker NS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | 2 | Specification developer | accessdata.fda.gov |
| Source, Brachytherapy, Radionuclide | KXK | 2 | Specification developer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | 2 | 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 |
|---|---|---|---|---|---|---|
| October 21, 2020 | K192771 | C4 Fiducial Marker | NEU | Substantially Equivalent | C4 Imaging, LLC | accessdata.fda.gov |
| April 27, 2018 | K180069 | HDR MRI Lumen Marker | JAQ | Substantially Equivalent | C4 Imaging, LLC | accessdata.fda.gov |
| August 25, 2017 | K171487 | Sirius MRI Marker NS | KXK | Substantially Equivalent | C4 Imaging, LLC | accessdata.fda.gov |
| November 20, 2013 | K131689 | MRI MARKER | KXK | Substantially Equivalent | C4 Imaging, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Marker, Radiographic, Implantable
- All makers of Source, Brachytherapy, Radionuclide
- All makers of System, Applicator, Radionuclide, Remote-Controlled
Updated October 21, 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.