510(k) · Cleared
ClearedMiplatform Medical Imaging Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hinacom Software and Technology, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jul 12, 2013 as substantially equivalent to K042292 (Stentor, Inc., 2004) and 1 other predicate after a 56-day review. Its family tree reaches back 10 generations to 1991. 1 later device descends from it.
- Decided
- Jul 12, 2013
- Review
- 56 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K913770 (1991). 40 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 2 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 1 generation backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- This deviceK131424 Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK171977 miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform…Hinacom Software and Technology, Ltd. · 2018
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 8 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 7 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 6 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 5 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 4 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 3 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 2 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 1 generation backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- This deviceK131424 Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −8 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −7 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −6 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −5 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −4 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −3 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −2 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −1 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| 0 (this device) | K131424 | Miplatform Medical Imaging Suite | Hinacom Software and Technology, Ltd. | 2013 | — |
| +1 | K171977 | miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer | Hinacom Software and Technology, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042292 | Isite PacsSummary page 6…stantially equivalent to several software applications that display, visualize, analyze and measure images and regions of interest. The predicate devices are iSite PACS (K042292) and Vitrea, Version 4.0 (K071331) which have been classified under 21 CFR 892.2050 as a Class 11 medical device. miPlatform is… | 2004 |
| * | K071331 | Vitrea Version 4.0Summary page 6…oftware applications that display, visualize, analyze and measure images and regions of interest. The predicate devices are iSite PACS (K042292) and Vitrea, Version 4.0 (K071331) which have been classified under 21 CFR 892.2050 as a Class 11 medical device. miPlatform is substantially equivalent to the id… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171977 | miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 9 of the 40 ancestors have a recall of any class.
- Of its descendants, K171977 (Hinacom Software and Technology, Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K042292.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (360 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131424: Miplatform Medical Imaging Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131424
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026