# K131424: Miplatform Medical Imaging Suite

- Pathway: 510(k) (Traditional)
- Applicant: Hinacom Software and Technology, Ltd.
- Decided: Jul 12, 2013 after 56 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K913770 (1991). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042292: Isite Pacs, Stentor, Inc. (2004) Summary page 6.
- K071331: Vitrea Version 4.0, Vital Images, Inc. (2007) Summary page 6.

## Most influential descendants
- K171977: miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer (2018), 0 descendants of its own

## Indications for use
miPlatform is an internet-based image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package that is used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data. The software performs digital image processing, analysis, reviewing, communication and storage. miPlatform supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MQ SC, VL, as well as hospital/radiology information systems and any other information systems that support DICOM 3.0 standard. miPlatform also supports multidimensional image visualization, measurement and analysis tools, and reporting algorithms. The user interface is designed to follow typical clinical workflow patterns to process, review, validate/edit and analyze digital images. The software supports the following image analysis options: Vessel Analysis is an option intended for viewing or displaying vascular obstructive disease by providing a non-invasive survey of a patient's coronary or peripheral arteries. Physicians can select any artery to view the following anatomical references: the highlighted vessel in 3D. two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Physicians can manually measure the lumen width to obtain percentage stenosis calculations. In addition, clinicians can manually measure vessel length along the centerline in standard curved MPR views and examine Houndsfield unit or signal intensity statistics. Coronary Calcium Scoring is an option intended for cardiac scoring from CT image derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Physicians can use semi-automatic tools in Coronary Calcium Scoring to mark calcified lesions of coronary arteries, and automated computation of Agatston scoring will be performed and presented in areport. miPlatform supports a real-time image-based conference option with integrated audio/video capability. Multiple users may log into the system and participate in the conference from different locations via internet connection. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K131424
Methodology: https://510kreport.com/methodology