MFI-Cardiac— 510(k) K173512

Substantially Equivalent

Multifunctional Imaging, LLC

FDA 510(k) clearance K173512 for MFI-Cardiac, Substantially Equivalent on 2018-02-05. Applicant: Multifunctional Imaging, LLC.

Clearance details

Applicant
Multifunctional Imaging, LLC
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Salt Lake, UT, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.