510(k) · Cleared
ClearedMediq Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clario Medical Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 5, 2005 as substantially equivalent to K993802 (Context Vision AB, 2000) and 6 other predicates after a 45-day review. Its family tree reaches back 7 generations to 1991. 11 later devices descend from it.
- Decided
- Dec 5, 2005
- Review
- 45 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K913770 (1991). 41 ancestors in all, the oldest K896095 (1990). 11 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 4 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 3 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 2 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 1 generation backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- This deviceK052963 Mediq Version 1.0Clario Medical Imaging, Inc. · 2005
- Descendant · cites it directly · 10 of its ownK080196 Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008
- Descendant · 2 generations on · 9 of its ownK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- Descendant · 3 generations on · 8 of its ownK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 4 of its ownK170195 QuantXQuantitative Insights, Inc. · 2017
- Descendant · 4 generations on · 3 of its ownK210670 BU-CADTaihao Medical, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K080196Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008 · cites it directly10descendants
- K081556Cadstream, Version 5.0Confirma, Inc. · 2009 · 2 generations on9descendants
- K092954Cadstream Version 5Confirma, Inc. · 2009 · 3 generations on8descendants
- K170195QuantXQuantitative Insights, Inc. · 2017 · 3 generations on4descendants
- K210670BU-CADTaihao Medical, Inc. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −5 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −4 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −3 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −2 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −1 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| 0 (this device) | K052963 | Mediq Version 1.0 | Clario Medical Imaging, Inc. | 2005 | — |
| +1 | K080196 | Z3D Contrast Acuity | Clario Medical Imaging, Inc. | 2008 | — |
| +2 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| +3 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| +3 | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| +4 | K210670 | BU-CAD | Taihao Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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 |
|---|---|---|---|
| * | K993802 | Sharpview Image Enhancement System Our reading of the summary gave K993082, FDA’s number for Exactech Acumatch Integrated Hip System a-Series Porous… (Exactech, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “SharpView”. | 2000 |
| * | K043333 | VITREA2, Version 3.7 Medical Image Processing SystemSummary page 1…K993082 Model: Vitrea 2, Version 3.7 Manufacturer: Vital Images 5 10 (k) Number: K043333 Original 510(k) PreMarket Notification 14 Clario Medical Inmaging, Inc.… | 2004 |
| * | K960265 | Advantage Windows with Functool OptionSummary page 2…FuncTool 2000, designed for Advantage Workstation Manufacturer: GE Medical Systems 510 (k) Number: K960265 Model: MIStar Manufacturer: Apollo Medical Imaging Technology Pty.… | 1996 |
| * | K043350 | Mistar, Model V3.2Summary page 2…Model: MIStar Manufacturer: Apollo Medical Imaging Technology Pty. Ltd. 510 (k) Number: K043350 Model: Syngo Colonography Software Package Manufacturer: Siemens Me… | 2004 |
| * | K030982 | Syngo Colonography Software PackageSummary page 2…del: Syngo Colonography Software Package Manufacturer: Siemens Medical Systems 510 (k) Number: K030982 Model: Realtime 3D Software Package Manufacturer: Siemens Medical S… | 2003 |
| * | K973010 | Realtime 3D Diagnostic WorkstationSummary page 2…Model: Realtime 3D Software Package Manufacturer: Siemens Medical Systems 510 (k) Number: K973010 Model: Fly Through PACS Software Manufacturer: Siemens Medical Syst… | 1997 |
| * | K971717 | Fly ThroughSummary page 2…Model: Fly Through PACS Software Manufacturer: Siemens Medical Systems 510 (k) Number: K971717 4. Device Description: MedIQ Version 1.0 is a software package designed to assist the radiologist in… | 1997 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080196 | Z3D Contrast Acuity | 2008 | 10 |
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 5 companies; a new generation was cleared every 11 months on median.
- 10 of the 41 ancestors have a recall of any class.
- Of its descendants, K080196 (Clario Medical Imaging, Inc., 2008) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K993802.
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?
MedIQ is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input. The software displays the temporal variation in dynamic data as a surface map that enhances…
Read the full statement (209 words)
MedIQ is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.
The software displays the temporal variation in dynamic data as a surface map that enhances visualization of pixel intensity and time/intensity changes extracted from CT and MR temporal data sets. The results may be displayed as either a grayscale enhancement or a color overlay on the selected image.
MedLQ also may be used to perform post-processing analysis of multi-modality, digital images, including MR, CT, X-Ray, PET and Nuclear Medicine images. The software analysis tools may be applied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections.
The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization, and a z-axis kinematic motion feature.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of MedIQ analysis. The MedlQ software is not intended for use for primary interpretation of digital mammography images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052963 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052963: Mediq Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052963
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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