510(k) · Cleared
ClearedMistar, Model V3.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apollo Medical Imaging Technology Pty., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Dec 15, 2004 as substantially equivalent to K020995 (Efilm Medical, Inc., 2002) and 2 other predicates after a 9-day review. Its family tree reaches back 5 generations to 1990. 12 later devices descend from it.
- Decided
- Dec 15, 2004
- Review
- 9 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K896095 (1990). 10 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 4 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 3 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 2 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 1 generation backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- This deviceK043350 Mistar, Model V3.2Apollo Medical Imaging Technology Pty., Ltd. · 2004
- Descendant · cites it directly · 11 of its ownK052963 Mediq Version 1.0Clario Medical Imaging, Inc. · 2005
- Descendant · 2 generations on · 10 of its ownK080196 Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008
- Descendant · 3 generations on · 9 of its ownK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- Descendant · 4 generations on · 8 of its ownK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 4 of its ownK170195 QuantXQuantitative Insights, Inc. · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K052963Mediq Version 1.0Clario Medical Imaging, Inc. · 2005 · cites it directly11descendants
- K080196Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008 · 2 generations on10descendants
- K081556Cadstream, Version 5.0Confirma, Inc. · 2009 · 3 generations on9descendants
- K092954Cadstream Version 5Confirma, Inc. · 2009 · 4 generations on8descendants
- K170195QuantXQuantitative Insights, Inc. · 2017 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −4 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −3 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −2 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −1 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| 0 (this device) | K043350 | Mistar, Model V3.2 | Apollo Medical Imaging Technology Pty., Ltd. | 2004 | — |
| +1 | K052963 | Mediq Version 1.0 | Clario Medical Imaging, Inc. | 2005 | — |
| +2 | K080196 | Z3D Contrast Acuity | Clario Medical Imaging, Inc. | 2008 | — |
| +3 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| +4 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| +4 | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K020995 | Efilm Workstation with ModulesSummary page 1…Device: Manufacturer Product 510(k) Number Clearance Date Efilni Medical, Inc. Efilrn Workstation with K020995 04/12/2002 Modules _____ -General Electric… | 2002 |
| * | K010042 | CT Perfusion 2Summary page 1…th K020995 04/12/2002 Modules _____ -General Electric CT Perfusion 2 K010042 0/0/2001 GE Medical Systems Advantage Windows K960265 0… | 2001 |
| * | K960265 | Advantage Windows with Functool OptionSummary page 1…_____ -General Electric CT Perfusion 2 K010042 0/0/2001 GE Medical Systems Advantage Windows K960265 07/03/1996 ____ ____ ____ ____ with Functool Option _ _ _ _ _ _… | 1996 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052963 | Mediq Version 1.0 | 2005 | 11 |
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 14 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K052963 (Clario Medical Imaging, Inc., 2005) has gone furthest, with 11 descendants of its own.
- 14 other devices also cite its predicate K020995.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
MIStar is a software package that provides manipulation, visualization and processing of medical images in a diagnostic imaging setting. It allows transfer of DICOM 3.0 images over a medical imaging network, and can receive digital images and data from various sources (including but not limited to CT, MR, NM, and PT). MIStar supports the analysis of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media. It…
Read the full statement (201 words)
MIStar is a software package that provides manipulation, visualization and processing of medical images in a diagnostic imaging setting. It allows transfer of DICOM 3.0 images over a medical imaging network, and can receive digital images and data from various sources (including but not limited to CT, MR, NM, and PT).
MIStar supports the analysis of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media. It allows visual inspection of time intensity curves and calculation of parametric parameters (i.e., area under curve, time to peak, maximum slope of enhancement, etc). It also calculates various blood perfusion related parameters such as blood flow (BF), blood volume (BV), mean transit time (MTT) and capillary permeability from dynamic CT images. This software provides supplemental information to those images extracted from CT and MR temporal datasets and will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability changes related but not limited to stroke or tumor angiogenesis and be helpful in therapy monitoring.
MIStar is intended to be used by trained medical professionals, including but not limited to licensed radiologists, technologists and clinicians, and for the rendering clinical diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043350 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043350: Mistar, Model V3.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043350
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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