The following data is part of a premarket notification filed by Multifunctional Imaging, Llc with the FDA for Mfi-cardiac.
| Device ID | K173512 |
| 510k Number | K173512 |
| Device Name: | MFI-Cardiac |
| Classification | System, Image Processing, Radiological |
| Applicant | MultiFunctional Imaging, LLC 551 E 50 N North Salt Lake, UT 84054 |
| Contact | Dan Kadrmas |
| Correspondent | Dan Kadrmas MultiFunctional Imaging, LLC 551 E 50 N North Salt Lake, UT 84054 |
| Product Code | LLZ |
| Subsequent Product Code | JAK |
| Subsequent Product Code | KPS |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860059002109 | K173512 | 000 |