FDA 510(k)

MFI-Cardiac

K-Number: K173512 · 2018-02-05

Decision Date2018-02-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MFI-Cardiac is the device name listed in this FDA 510(k) record. The listed applicant is Multifunctional Imaging, LLC. It received FDA 510(k) clearance on 2018-02-05 under 510(k) number K173512. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MFI-Cardiac?

MFI-Cardiac is a medical device that received FDA 510(k) clearance on 2018-02-05. The listed applicant is Multifunctional Imaging, LLC. The 510(k) number is K173512.

When did MFI-Cardiac receive FDA 510(k) clearance?

MFI-Cardiac received FDA 510(k) clearance on 2018-02-05, under 510(k) number K173512.

Who is the listed applicant for MFI-Cardiac?

The FDA 510(k) record lists Multifunctional Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MFI-Cardiac?

The FDA product code for MFI-Cardiac is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.