510(k) · Cleared
ClearedMirada RTX
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 Mar 20, 2013 as substantially equivalent to K102687 (Mirada Medical, Ltd., 2010) and 3 other predicates after a 33-day review. Its family tree reaches back 11 generations to 1991. 36 later devices descend from it.
- Decided
- Mar 20, 2013
- Review
- 33 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K913770 (1991). 111 ancestors in all, the oldest K871859 (1987). 36 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 1 generation backK102687 Mirada RTMirada Medical, Ltd. · 2010
- This deviceK130393 Mirada RTXMirada Medical, Ltd. · 2013
- Descendant · cites it directly · 25 of its ownK181572 Workflow BoxMirada Medical, Ltd. · 2018
- Descendant · cites it directly · 8 of its ownK132045 Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013
- Descendant · cites it directly · 7 of its ownK200323 AutoContourRadformation, Inc. · 2020
- Descendant · 2 generations on · 7 of its ownK132944 Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
- Descendant · 2 generations on · 6 of its ownK220598 AutoContour Model RADAC V2Radformation, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 9 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 8 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 7 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 6 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 4 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 1 generation backK102687 Mirada RTMirada Medical, Ltd. · 2010
- This deviceK130393 Mirada RTXMirada Medical, Ltd. · 2013
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K181572Workflow BoxMirada Medical, Ltd. · 2018 · cites it directly25descendants
- K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013 · cites it directly8descendants
- K200323AutoContourRadformation, Inc. · 2020 · cites it directly7descendants
- K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014 · 2 generations on7descendants
- K220598AutoContour Model RADAC V2Radformation, Inc. · 2022 · 2 generations on6descendants
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 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −9 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −8 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −7 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −6 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −4 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −2 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −1 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| 0 (this device) | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| +1 | K181572 | Workflow Box | Mirada Medical, Ltd. | 2018 | — |
| +1 | K132045 | Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options | Ge Hungary Kft | 2013 | — |
| +1 | K200323 | AutoContour | Radformation, Inc. | 2020 | — |
| +2 | K132944 | Advantagesim MD MR Pelvic Organ at Risk Segmentation | Ge Hungary Kft | 2014 | — |
| +2 | K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | 2022 | — |
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 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K102687 | Mirada RTSummary page 1…y Equivalent to the following Legally Marketed devices: Predicate Devices 510(k) Number Trade Name Manufacturer K102687 Mirada RT Mirada Medical Ltd K091373 Syngo TrueD) Software… | 2010 |
| * | K091373 | Syngo TruedSummary page 1…510(k) Number Trade Name Manufacturer K102687 Mirada RT Mirada Medical Ltd K091373 Syngo TrueD) Software Siemens Medical Solutions USA, Inc. K093982 XELERIS 3 P… | 2009 |
| * | K093982 | Xeleris 3 Processing and Review WorkstationSummary page 1…Mirada RT Mirada Medical Ltd K091373 Syngo TrueD) Software Siemens Medical Solutions USA, Inc. K093982 XELERIS 3 PROCESSING AND GE Healthcare REVIEW WORKSTATION K0810… | 2010 |
| * | K081076 | Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseSummary page 1…Medical Solutions USA, Inc. K093982 XELERIS 3 PROCESSING AND GE Healthcare REVIEW WORKSTATION K081076 VelocityAlS Velocity Medical Solutions, LLC B.1.1 Intended Use RTx is intend… | 2008 |
What descends from it? (36)
See all 365 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 companies; a new generation was cleared every 1.5 years on median.
- 25 of the 111 ancestors have a recall of any class.
- Of its descendants, K181572 (Mirada Medical, Ltd., 2018) has gone furthest, with 25 descendants of its own.
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?
RTx is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, radiation oncologists, dlosimetrists and physicists. RTx is a software application intended to display and visualize 20 & 3D 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…
Read the full statement (287 words)
RTx is intended to be used by trained medical professionals including, but not limited to, radiologists,
nuclear medicine physicians, radiation oncologists, dlosimetrists and physicists.
RTx is a software application intended to display and visualize 20 & 3D 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 static and gated CT, PET,
MR, SPECT and planar NM. The user may also create, display, print, store and distribute reports
resulting from interpretation of the dlatasets.
RTx 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.
RTx 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.
RTx supports the loading and saving of DICOM RT objects and allows the user to define, import, display,
transform, store and export such objects including regions of interest structures and dose volumes to
radiation therapy planning systems. RTx allows the user to transform regions of interest associated with
a particular imaging dlataset to another, supporting atlas-based contouring and rapid re-contouring of
the same patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130393 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130393: Mirada RTX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130393
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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