The following data is part of a premarket notification filed by Cardiovascular Imaging Technologies, Llc with the FDA for Imagenpro.
| Device ID | K050366 |
| 510k Number | K050366 |
| Device Name: | IMAGENPRO |
| Classification | System, Tomography, Computed, Emission |
| Applicant | CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC 200 N.E. MULBERRY Lee's Summit, MO 64086 |
| Contact | Melanie Hasek |
| Correspondent | Melanie 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 | 2005-02-14 |
| Decision Date | 2005-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862611000318 | K050366 | 000 |