The following data is part of a premarket notification filed by Cardiovascular Imaging Technologies, Llc with the FDA for Imagenmd.
| Device ID | K041671 |
| 510k Number | K041671 |
| Device Name: | IMAGENMD |
| Classification | System, Tomography, Computed, Emission |
| Applicant | CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC 200 N.E. MULBERRY Lee's Summit, MO 64086 |
| Contact | Malinie Hasek |
| Correspondent | Malinie Hasek CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC 200 N.E. MULBERRY Lee's Summit, MO 64086 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-21 |
| Decision Date | 2004-07-22 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IMAGENMD 78317579 2951476 Live/Registered |
Cardiovascular Imaging Technologies L.L.C. 2003-10-23 |