FDA 510(k)

AutoMIStar

K-Number: K192912 · 2019-12-31

ApplicantApollo Medical Imaging Technology Pty. , Ltd.

Decision Date2019-12-31

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AutoMIStar is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Medical Imaging Technology Pty. , Ltd.. It received FDA 510(k) clearance on 2019-12-31 under 510(k) number K192912. 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 AutoMIStar?

AutoMIStar is a medical device that received FDA 510(k) clearance on 2019-12-31. The listed applicant is Apollo Medical Imaging Technology Pty. , Ltd.. The 510(k) number is K192912.

When did AutoMIStar receive FDA 510(k) clearance?

AutoMIStar received FDA 510(k) clearance on 2019-12-31, under 510(k) number K192912.

Who is the listed applicant for AutoMIStar?

The FDA 510(k) record lists Apollo Medical Imaging Technology Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AutoMIStar?

The FDA product code for AutoMIStar 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.