510(k) · Cleared
ClearedMyrian 1.4
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 Jun 29, 2009 as substantially equivalent to K052995 (GE Healthcare, 2005) and 3 other predicates after an 82-day review. Its family tree reaches back 10 generations to 1991. 7 later devices descend from it.
- Decided
- Jun 29, 2009
- Review
- 82 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K913770 (1991). 44 ancestors in all, the oldest K871859 (1987). 7 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 2 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 1 generation backK071000 MyrianIntrasense · 2007
- This deviceK091001 Myrian 1.4Intrasense · 2009
- Descendant · cites it directly · 6 of its ownK113620 Myrian 1.11Intrasense · 2012
- Descendant · 2 generations on · 2 of its ownK160334 Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas · 2016
- Descendant · 2 generations on · 2 of its ownK130552 CT Pulmonary AnalysisQi Imaging, LLC · 2014
- Descendant · 3 generations on · 1 of its ownK211655 aPROMISEExini Diagnostics AB · 2021
- Descendant · 3 generations on · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 8 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 7 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 6 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 5 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 4 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 3 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 2 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 1 generation backK071000 MyrianIntrasense · 2007
- This deviceK091001 Myrian 1.4Intrasense · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K113620Myrian 1.11Intrasense · 2012 · cites it directly6descendants
- K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas · 2016 · 2 generations on2descendants
- K130552CT Pulmonary AnalysisQi Imaging, LLC · 2014 · 2 generations on2descendants
- K211655aPROMISEExini Diagnostics AB · 2021 · 3 generations on1descendant
- K181892Ziostation2Ziosoft, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −8 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −7 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −6 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −5 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −4 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −3 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −2 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −1 | K071000 | Myrian | Intrasense | 2007 | — |
| 0 (this device) | K091001 | Myrian 1.4 | Intrasense | 2009 | — |
| +1 | K113620 | Myrian 1.11 | Intrasense | 2012 | — |
| +2 | K160334 | Advanced Medical Imaging Software Suite (KSWVWR) | Keosys Sas | 2016 | — |
| +2 | K130552 | CT Pulmonary Analysis | Qi Imaging, LLC | 2014 | — |
| +3 | K211655 | aPROMISE | Exini Diagnostics AB | 2021 | — |
| +3 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K052995 | Advantage Workstation 4.3.Summary page 1…essing, Radiological Code product LLZ Panel 892 Regulation number 892.=2050 Regulatory class II Predicate devices [K052995] Cleared [November 8, 2005] [General Electric Medical Systems] [Advantage Workstation Version 4.3], manuf… | 2005 |
| * | K061624 | Vitrea, Version 3.9Summary page 1…ystems] [Advantage Workstation Version 4.3], manufactured by [General Electric Medical Systems] [K061624] Cleared [June 27, 2006] [Vital Images, Inc.] [Vitrea2 Version 3.9], manufactured by [Vital Images, Inc.]… | 2006 |
| * | K082228 | Planisight LinasysSummary page 1…[K061624] Cleared [June 27, 2006] [Vital Images, Inc.] [Vitrea2 Version 3.9], manufactured by [Vital Images, Inc.] [K082228] Cleared [July 31, 2008] [Pathfinder Therapeutics, Inc] [Planisight LinasysT], manufactured by [Pathfinde… | 2008 |
| * | K071000 | MyrianSummary page 1…red [July 31, 2008] [Pathfinder Therapeutics, Inc] [Planisight LinasysT], manufactured by [Pathfinder Therapeutics, Inc] [K071000] Cleared [May 14, 2007] [intrasense], manufactured by [ihtrasense SAS] Description The Myrian® System is a software… | 2007 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113620 | Myrian 1.11 | 2012 | 6 |
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 18 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 11 of the 44 ancestors have a recall of any class.
- Of its descendants, K113620 (Intrasense, 2012) has gone furthest, with 6 descendants of its own.
- 7 other devices also cite its predicate K052995.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 multi modality medical diagnostic device. It is aimed at reviewing and analyzing anatomy and pathology. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user, It provides user a set of tools meant to create and modify objects of interest: points of interest, annotations of interest and…
Read the full statement (127 words)
Myrian is a multi modality medical diagnostic device. It is aimed at reviewing and analyzing anatomy and pathology. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user, It provides user a set of tools meant to create and modify objects of interest: points of interest, annotations of interest and volumes of interest.
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. Mammographic 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/K091001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091001: Myrian 1.4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091001
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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