The following data is part of a premarket notification filed by Cardiovascular Imaging Technologies with the FDA for Imagen3d.
| Device ID | K122241 |
| 510k Number | K122241 |
| Device Name: | IMAGEN3D |
| Classification | System, Tomography, Computed, Emission |
| Applicant | CARDIOVASCULAR IMAGING TECHNOLOGIES 9755 RIDGE DRIVE Lenexa, KS 66219 |
| Contact | Melanie Hasek |
| Correspondent | Melanie Hasek CARDIOVASCULAR IMAGING TECHNOLOGIES 9755 RIDGE DRIVE Lenexa, KS 66219 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-27 |
| Decision Date | 2012-10-24 |
| Summary: | summary |