510(k) · Cleared
ClearedMyrian 1.11
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intrasense · LLZ System, Image Processing, Radiological
Cleared on Jul 12, 2012 as substantially equivalent to K081985 (Ge Medical Systems, LLC, 2008) and 5 other predicates after a 218-day review. Its family tree reaches back 11 generations to 1991. 6 later devices descend from it.
- Decided
- Jul 12, 2012
- Review
- 218 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K913770 (1991). 163 ancestors in all, the oldest K871859 (1987). 6 later devices descend from it, 2 citing it directly.
- 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 backK071000 MyrianIntrasense · 2007
- 1 generation backK091001 Myrian 1.4Intrasense · 2009
- This deviceK113620 Myrian 1.11Intrasense · 2012
- Descendant · cites it directly · 2 of its ownK160334 Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas · 2016
- Descendant · cites it directly · 2 of its ownK130552 CT Pulmonary AnalysisQi Imaging, LLC · 2014
- Descendant · 2 generations on · 1 of its ownK211655 aPROMISEExini Diagnostics AB · 2021
- Descendant · 2 generations on · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK220590 aPROMISE XExini Diagnostics AB · 2022
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 backK071000 MyrianIntrasense · 2007
- 1 generation backK091001 Myrian 1.4Intrasense · 2009
- This deviceK113620 Myrian 1.11Intrasense · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas · 2016 · cites it directly2descendants
- K130552CT Pulmonary AnalysisQi Imaging, LLC · 2014 · cites it directly2descendants
- K211655aPROMISEExini Diagnostics AB · 2021 · 2 generations on1descendant
- K181892Ziostation2Ziosoft, Inc. · 2018 · 2 generations on1descendant
- K220590aPROMISE XExini Diagnostics AB · 2022 · 3 generations on0descendants
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 | K071000 | Myrian | Intrasense | 2007 | — |
| −1 | K091001 | Myrian 1.4 | Intrasense | 2009 | — |
| 0 (this device) | K113620 | Myrian 1.11 | Intrasense | 2012 | — |
| +1 | K160334 | Advanced Medical Imaging Software Suite (KSWVWR) | Keosys Sas | 2016 | — |
| +1 | K130552 | CT Pulmonary Analysis | Qi Imaging, LLC | 2014 | — |
| +2 | K211655 | aPROMISE | Exini Diagnostics AB | 2021 | — |
| +2 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | — |
| +3 | K220590 | aPROMISE X | Exini Diagnostics AB | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 9 | 0 |
| 1997 | 8 | 0 |
| 1998 | 11 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 16 | 0 |
| 2002 | 12 | 0 |
| 2003 | 6 | 0 |
| 2004 | 14 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 7 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (6)
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 |
|---|---|---|---|
| * | K081985 | AW ServerSummary page 1…ode product LLZ Panel 892 Regulation number 892.2050 Regulatory class II Predicate Devices [1<081985] Cleared [September 25, 20081 [Advantage Workstation Server], manufactured by [General Electric Healthcare]; [K<061624] Cleared [… | 2008 |
| * | K061624 | Vitrea, Version 3.9Summary page 4…ge (printing, CD burning, storing. This intended use is substantially equivalent to the one of the predicate devices Advantage Workstation Server (KO8i 985) and Vitrea2 (K061624). Myrian provides user with annotations, measurement, quantification and reporting tools, These features are substantially equi… | 2006 |
| * | K082228 | Planisight LinasysSummary page 1…], manufactured by [General Electric Healthcare]; [K<061624] Cleared [June 27, 2006] [Vital Images, Inc.) [Vitrea2 Version 3.9], manufactured by [Vital Images, Inc.]; [1<082228] Cleared [Juty 31, 2008] (Planisight Linasys] [LSPS], manufactured by [Pathfinder Therapeutics Inc.]. [1<091001] Cleared [June 29… | 2008 |
| * | K091001 | Myrian 1.4Summary page 1…a2 Version 3.9], manufactured by [Vital Images, Inc.]; [1<082228] Cleared [Juty 31, 2008] (Planisight Linasys] [LSPS], manufactured by [Pathfinder Therapeutics Inc.]. [1<091001] Cleared [June 29, 2009] [intrasense] [Myrian vi .4), manufactured by [intrasense] [1<093621] Cleared [February 23. 2010] [syngo.… | 2009 |
| * | K093621 | Syngo.Pet&CT OncologySummary page 1…anisight Linasys] [LSPS], manufactured by [Pathfinder Therapeutics Inc.]. [1<091001] Cleared [June 29, 2009] [intrasense] [Myrian vi .4), manufactured by [intrasense] [1<093621] Cleared [February 23. 2010] [syngo.PET&CT Oncology], manufactured by [Siemens Medical Solutions USA, Inc] [K073194) Cleared [Nov… | 2010 |
| * | K073194 | Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia ToolsSummary page 1…sense] [Myrian vi .4), manufactured by [intrasense] [1<093621] Cleared [February 23. 2010] [syngo.PET&CT Oncology], manufactured by [Siemens Medical Solutions USA, Inc] [K073194) Cleared [November 10, 2007) [CMRtools and plug-ins VentricularTools & ThalassaemiaTools, manufactured by [Cardiovascular Imaging… | 2008 |
What descends from it? (6)
2 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 21 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 40 of the 163 ancestors have a recall of any class.
- Of its descendants, K160334 (Keosys Sas, 2016) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K081985.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Myrian® is a software medical device aimed at reviewing images produced by all standard medical imaging devices. It also includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. Myrian® can be run from any standard client platform (such as PC) that might bf purchased independently by the end user. Common Users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This…
Read the full statement (117 words)
Myrian® is a software medical device aimed at reviewing images produced by all standard medical imaging devices. It also includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. Myrian® can be run from any standard client platform (such as PC) that might bf purchased independently by the end user.
Common Users are trained medical professionals, including surgeons, radiologist clinicians and technicians.
This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mainrographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113620: Myrian 1.11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113620
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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