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

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171977

by Hinacom Software and Technology, Ltd.

Identifiers

510(k) Number
K171977 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer is an internet-based image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. It is an upgrade of miPlatform medical imaging suite v2.0, previously cleared under K131424, and functions as the extension application software of the miPlatform medical imaging information system.

The software is installed on PC, smart mobile phone and other mobile terminals, enabling users to achieve mobile office functionality. It received FDA 510(k) clearance under K171977 on August 2, 2018, following a traditional review process. The device is manufactured by Hinacom Software and Technology, Ltd., located in Beijing, China.

Frequently asked questions

What is the miPlatform medical imaging suite v3.0 with miPlatform ZFP Viewer used for?

It is an internet-based image management system intended for use by trained professionals such as physicians, nurses, and medical technicians to manage and view medical images, supporting mobile office functionality across PC, smartphone, and other mobile terminals.

How is the miPlatform medical imaging suite v3.0 supplied and accessed?

The software is installed on PC, smart mobile phone, and other mobile terminals, allowing users to access the system remotely and achieve mobile office functionality as an extension of the miPlatform medical imaging information system.

Is the miPlatform medical imaging suite v3.0 a new device or an upgrade?

It is an upgrade of the miPlatform medical imaging suite v2.0, which was previously cleared under K131424, and functions as extension application software for the existing miPlatform medical imaging information system.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K171977 FDA 510(k) - miPlatform medical imaging suite v3.0 (..., miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ..., PDF Hinacom Software and Technology, Ltd., miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hinacom Software and Technology, Ltd.

Sources (1)

  • FDA 510(k) K171977 24 fields · synced Sep 24, 2026