The following data is part of a premarket notification filed by Cardiovascular Imaging Technologies with the FDA for Imagenuniversal.
| Device ID | K173547 |
| 510k Number | K173547 |
| Device Name: | ImagenUniversal |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Cardiovascular Imaging Technologies 4320 Wornall Road, Suite 114 Kansas City, UT 64111 |
| Contact | James A. Case |
| Correspondent | Melanie K. Hasek PRA Health Sciences 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 | 2017-11-16 |
| Decision Date | 2018-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862611000332 | K173547 | 000 |