The following data is part of a premarket notification filed by Cardiovascular Imaging Technologies with the FDA for Imagenspect.
| Device ID | K152503 |
| 510k Number | K152503 |
| Device Name: | ImagenSPECT |
| Classification | System, Tomography, Computed, Emission |
| Applicant | CARDIOVASCULAR IMAGING TECHNOLOGIES 4320 WORNALL ROAD, SUITE 114 Kansas City, MO 64111 |
| Contact | James Case |
| Correspondent | Melanie 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 | 2015-09-02 |
| Decision Date | 2016-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862611000301 | K152503 | 000 |
| 00862611000349 | K152503 | 000 |