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FDA 510(k)

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer

K-Number: K171977 · 2018-08-02

ApplicantHinacom Software and Technology, Ltd.
Decision Date2018-08-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Hinacom Software and Technology, Ltd.. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K171977. 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 miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer?

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Hinacom Software and Technology, Ltd.. The 510(k) number is K171977.

When did miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer receive FDA 510(k) clearance?

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer received FDA 510(k) clearance on 2018-08-02, under 510(k) number K171977.

Who is the listed applicant for miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer?

The FDA 510(k) record lists Hinacom Software and Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer?

The FDA product code for miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer 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, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid 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.

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