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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 Clinical Trials

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.

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Other records listing Apollo Medical Imaging Technology Pty. , Ltd. 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.

K043350MISTAR, MODEL V3.2

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.

K263048Syngo Carbon Space (VA4)Siemens Healthineers AGK261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.

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.

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