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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 a medical device manufactured by Hinacom Software and Technology, Ltd.. It received FDA 510(k) clearance on 2018-08-02 under approval 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. It is manufactured by Hinacom Software and Technology, Ltd.. The 510(k) number is K171977.

When was miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer approved by the FDA?

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

What company makes 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 manufactured by Hinacom Software and Technology, Ltd..

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.

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Related PubMed Literature

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Official Source

View on FDA Database →

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