Data / Medical devices / United States / Cardiovascular Imaging Technologies, LLC
Cardiovascular Imaging Technologies, LLC: FDA-registered device maker in Kansas City, MO, United States, 5 510(k) clearances
Cardiovascular Imaging Technologies, LLC is registered with the FDA (registration 3004504920) in Kansas City, MO, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 11, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004504920
- Address
- 4320 Wornall Rd Ste 114, Kansas City, MO, United States, 64111
- Owner or operator
- CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC (9059156)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2027
- Brand names listed
- ImagenPRO, ImagenQ, ImagenSPECT, ImagenSPECT 3, ImagenUniversal
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 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 |
|---|---|---|---|---|---|---|
| August 11, 2020 | K201933 | ImagenSPECT 3.0 | KPS | Substantially Equivalent | Cardiovascular Imaging Technologies | accessdata.fda.gov |
| January 12, 2018 | K173547 | ImagenUniversal | KPS | Substantially Equivalent | Cardiovascular Imaging Technologies | accessdata.fda.gov |
| January 25, 2016 | K152503 | ImagenSPECT | KPS | Substantially Equivalent | Cardiovascular Imaging Technologies | accessdata.fda.gov |
| April 9, 2008 | K080770 | IMAGENMD WITH IMAGENQ | LLZ | Substantially Equivalent | Cardiovascular Imaging Technologies, LLC | accessdata.fda.gov |
| March 17, 2005 | K050366 | IMAGENPRO | KPS | Substantially Equivalent | Cardiovascular Imaging Technologies, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Tomography, Computed, Emission
- All makers of System, Image Processing, Radiological
Updated August 11, 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.