FDA 510(k)

Fusion Bx

K-Number: K153166 · 2016-01-25

Decision Date2016-01-25

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Fusion Bx is the device name listed in this FDA 510(k) record. The listed applicant is Focal Healtcare, Inc.. It received FDA 510(k) clearance on 2016-01-25 under 510(k) number K153166. 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 Fusion Bx?

Fusion Bx is a medical device that received FDA 510(k) clearance on 2016-01-25. The listed applicant is Focal Healtcare, Inc.. The 510(k) number is K153166.

When did Fusion Bx receive FDA 510(k) clearance?

Fusion Bx received FDA 510(k) clearance on 2016-01-25, under 510(k) number K153166.

Who is the listed applicant for Fusion Bx?

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

What is the FDA product code for Fusion Bx?

The FDA product code for Fusion Bx 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.