510(k) · Cleared
ClearedmiPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
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 Aug 2, 2018 as substantially equivalent to K131424 (Hinacom Software and Technology, Ltd., 2013) and 1 other predicate after a 398-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Aug 2, 2018
- Review
- 398 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K913770 (1991). 44 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 1 generation backK131424 Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd. · 2013
- This deviceK171977 miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform…Hinacom Software and Technology, Ltd. · 2018
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 9 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 8 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 7 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 6 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 5 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 4 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 1 generation backK131424 Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd. · 2013
- This deviceK171977 miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform…Hinacom Software and Technology, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −9 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −8 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −7 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −6 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −5 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −4 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −3 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −2 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −1 | K131424 | Miplatform Medical Imaging Suite | Hinacom Software and Technology, Ltd. | 2013 | — |
| 0 (this device) | 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 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K131424 | Miplatform Medical Imaging SuiteSummary page 3…Indications for Use (Describe) miPlatform medical imaging suite v3.0 (miPlaftorm v3.0) is an upgrade of miPlatform medical imaging suite v2.0, previous cleared under K131424. miPlatform v3.0 is an internet-based image management system intended to be used by trained professionals, including but not lim… | 2013 |
| * | K132824 | Carestream Vue Pacs Version 11.4 Carestream Vue Motion ApplicationSummary page 4…Vue PACS v11.4 Vue Motion Common/Usual Name: Picture Archiving and Communications System Classification Name: LLZ, Class II, 21 CFR 892.2050 510(k) Number: K132824 7‐1 7.3. Indi… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 10 of the 44 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 medical imaging suite v3.0 (miPlaftorm v3.0) is an upgrade of miPlatform medical imaging suite v2.0, previous cleared under K131424. miPlatform v3.0 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…
Read the full statement (350 words)
miPlatform medical imaging suite v3.0 (miPlaftorm v3.0) is an upgrade of miPlatform medical imaging suite v2.0, previous cleared under K131424. miPlatform v3.0 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 patient data. The software supports and performs reviewing, communication and storage from the following modalities through DICOM 3.0 standard: CT, MR, NM, US, XA, PET, DX, CR/DR, RF, RT, MG, SC, VL, ES, OP, XC, PT, OT, as well as hospital/radiology information systems and any other information systems that support DICOM 3.0 standards. Non-radiology modalities are not for diagnostic use. For radiology modalities, only FDA cleared monitors shall be used to review images for diagnostic use.
miPlatform ZFP Viewer is offered as extension application to miPlatform medical imaging suite system. This software technology uses HTML5 which allows a browser-enabled device to run the software application, and thus requires no installation (zero foot print). The user is able to access patient images and study reports from a mobile device, such as iPad3, as well as personal computer using Microsoft Windows System, anywhere through a wireless and 3G, 4G network. miPlatform ZFP Viewer has a simple GUI for viewing and includes tools such as zoom, pan, windowing, basic measurement, and 3D visualization functions, including volume rendering and multi-planar reconstruction. Only FDA cleared monitors shall be used to review images for diagnostic use.
miPlatform ZFP Viewer provides wireless and portable access to medical images, in addition to standard intranet or internet access. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. When used on a mobile device, the miPlatform ZFP Viewer is not for diagnostic use.
For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by the FDA for mammography. MIP/MRP tools are not supported for mammography images for diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171977 · printed Nov 5, 2026
Cite this page
510(k) Report. “K171977: miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171977
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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