FDA 510(k)

ProFuse CAD

K-Number: K173744 · 2018-11-21

ApplicantEigen

Decision Date2018-11-21

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ProFuse CAD is the device name listed in this FDA 510(k) record. The listed applicant is Eigen. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K173744. 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 ProFuse CAD?

ProFuse CAD is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Eigen. The 510(k) number is K173744.

When did ProFuse CAD receive FDA 510(k) clearance?

ProFuse CAD received FDA 510(k) clearance on 2018-11-21, under 510(k) number K173744.

Who is the listed applicant for ProFuse CAD?

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

What is the FDA product code for ProFuse CAD?

The FDA product code for ProFuse CAD is LLZ.

Other records listing Eigen as applicant

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.

K222222Artemis, Artemis TPO, Artemis MX K162474Artemis

Related Devices (Code: LLZ)

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

View on FDA Database →

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