510(k) · Cleared
ClearedMirada XD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mirada Medical, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jun 23, 2010 as substantially equivalent to K071964 (Mimvista Corp., 2007) and 3 other predicates after a 51-day review. Its family tree reaches back 9 generations to 1991. 70 later devices descend from it.
- Decided
- Jun 23, 2010
- Review
- 51 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K913770 (1991). 106 ancestors in all, the oldest K871859 (1987). 70 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations between
- 3 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 2 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- This deviceK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · cites it directly · 37 of its ownK102687 Mirada RTMirada Medical, Ltd. · 2010
- Descendant · 2 generations on · 36 of its ownK130393 Mirada RTXMirada Medical, Ltd. · 2013
- Descendant · 3 generations on · 25 of its ownK181572 Workflow BoxMirada Medical, Ltd. · 2018
- Descendant · cites it directly · 11 of its ownK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- Descendant · 2 generations on · 9 of its ownK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
Show all 9 generations
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 7 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 6 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 5 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 4 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 3 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 2 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- This deviceK101228 Mirada XDMirada Medical, Ltd. · 2010
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K102687Mirada RTMirada Medical, Ltd. · 2010 · cites it directly37descendants
- K130393Mirada RTXMirada Medical, Ltd. · 2013 · 2 generations on36descendants
- K181572Workflow BoxMirada Medical, Ltd. · 2018 · 3 generations on25descendants
- K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018 · cites it directly11descendants
- K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −8 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −7 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −6 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −5 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −4 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −3 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −2 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −1 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| 0 (this device) | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +1 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| +2 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| +3 | K181572 | Workflow Box | Mirada Medical, Ltd. | 2018 | — |
| +1 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
| +2 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 8 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 9 | 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? (4)
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 |
|---|---|---|---|
| * | K071964 | Mim 4.1 (Seastar)Summary page 1…XD is Substantially Equivalent to the following Legally Marketed devices: Predicate Devices 510(k) Number Trade Name Manufacturer K071964 MiM 4.1 (SEASTAR) MlMvista Corp. K(091373 Syngo TrueD) Software… | 2007 |
| * | K091373 | Syngo TruedSummary page 1…te Devices 510(k) Number Trade Name Manufacturer K071964 MiM 4.1 (SEASTAR) MlMvista Corp. K(091373 Syngo TrueD) Software Siemens Medical Solutions USA, Inc K(093982 XELERIS 3… | 2009 |
| * | K093982 | Xeleris 3 Processing and Review WorkstationSummary page 1…MiM 4.1 (SEASTAR) MlMvista Corp. K(091373 Syngo TrueD) Software Siemens Medical Solutions USA, Inc K(093982 XELERIS 3 PROCESSING AND GE Healthcare REVIEW WORKSTATION K(033955… | 2010 |
| * | K033955 | RTISTSummary page 1…Siemens Medical Solutions USA, Inc K(093982 XELERIS 3 PROCESSING AND GE Healthcare REVIEW WORKSTATION K(033955 RTist Mirada Solutions Ltd 1.1.1 Intended Use Mirada XD is intended… | 2004 |
What descends from it? (70)
See all 706 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102687 | Mirada RT | 2010 | 37 |
| K173088 | Vitrea Software Toshiba Package VSTP-001A | 2018 | 11 |
| K113244 | Synapse MPR Fusion | 2011 | 9 |
| K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature… | 2017 | 5 |
| K160334 | Advanced Medical Imaging Software Suite (KSWVWR) | 2016 | 2 |
| K220779 | XD | 2022 | 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 19 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 24 of the 106 ancestors have a recall of any class.
- Of its descendants, K102687 (Mirada Medical, Ltd., 2010) has gone furthest, with 37 descendants of its own.
- 9 other devices also cite its predicate K071964.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Mirada XD is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists. Mirada XD is a software application intended to display and visualize 20 & 30 multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include, CT, MR, PET…
Read the full statement (250 words)
Mirada XD is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists.
Mirada XD is a software application intended to display and visualize 20 & 30 multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include, CT, MR, PET, SPECT and planar NM. The user may also create, display, print, store and distribute reports resulting from interpretation of the datasets.
Mirada XD allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison of image data by the user. The result of the registration operation can assist the user in assessing changes in image data, either within or between examinations and aims to help the user obtain a better understanding of the combined information that would otherwise have to be visually compared disjointedly.
Mirada XD provides a number of tools such as rulers and region of interests, which are intended to be used for the assessment of regions of an image to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of lesions, determination of treatment response and follow-up.
Mirada XD allows the user to define, transform and store and export regions of interest structures in DICOM format including RT format for use in radiation therapy planning systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101228: Mirada XD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101228
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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