The following data is part of a premarket notification filed by Cardiovascular Imaging Technologies, Llc with the FDA for Imagenmd With Imagenq.
| Device ID | K080770 |
| 510k Number | K080770 |
| Device Name: | IMAGENMD WITH IMAGENQ |
| Classification | System, Image Processing, Radiological |
| Applicant | CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC 9755 RIDGE DR. Lenexa, KS 66219 |
| Contact | Melanie Hasek |
| Correspondent | Melanie Hasek CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC 9755 RIDGE DR. Lenexa, KS 66219 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-18 |
| Decision Date | 2008-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862611000325 | K080770 | 000 |