510(k) · Cleared
ClearedMyrian
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 May 14, 2007 as substantially equivalent to K052995 (GE Healthcare, 2005) and 1 other predicate after a 35-day review. Its family tree reaches back 9 generations to 1991. 8 later devices descend from it.
- Decided
- May 14, 2007
- Review
- 35 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K913770 (1991). 37 ancestors in all, the oldest K871859 (1987). 8 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations between
- 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 2 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 1 generation backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- This deviceK071000 MyrianIntrasense · 2007
- Descendant · cites it directly · 7 of its ownK091001 Myrian 1.4Intrasense · 2009
- Descendant · 2 generations on · 6 of its ownK113620 Myrian 1.11Intrasense · 2012
- Descendant · 3 generations on · 2 of its ownK160334 Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas · 2016
- Descendant · 3 generations on · 2 of its ownK130552 CT Pulmonary AnalysisQi Imaging, LLC · 2014
- Descendant · 4 generations on · 1 of its ownK211655 aPROMISEExini Diagnostics AB · 2021
Show all 9 generations
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 7 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 6 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 5 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 4 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 2 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 1 generation backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- This deviceK071000 MyrianIntrasense · 2007
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K091001Myrian 1.4Intrasense · 2009 · cites it directly7descendants
- K113620Myrian 1.11Intrasense · 2012 · 2 generations on6descendants
- K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas · 2016 · 3 generations on2descendants
- K130552CT Pulmonary AnalysisQi Imaging, LLC · 2014 · 3 generations on2descendants
- K211655aPROMISEExini Diagnostics AB · 2021 · 4 generations on1descendant
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 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −7 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −6 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −5 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −4 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −3 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −2 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −1 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| 0 (this device) | K071000 | Myrian | Intrasense | 2007 | — |
| +1 | K091001 | Myrian 1.4 | Intrasense | 2009 | — |
| +2 | K113620 | Myrian 1.11 | Intrasense | 2012 | — |
| +3 | K160334 | Advanced Medical Imaging Software Suite (KSWVWR) | Keosys Sas | 2016 | — |
| +3 | K130552 | CT Pulmonary Analysis | Qi Imaging, LLC | 2014 | — |
| +4 | K211655 | aPROMISE | Exini Diagnostics AB | 2021 | — |
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 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (2)
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…892 Regulation number 892=2050 Regulatory class II Predicate devices [K052995[ Cleared [November 8, 2005] [General Electric Medical Systems] [Advantage Workstation Ve… | 2005 |
| * | K061624 | Vitrea, Version 3.9Summary page 1…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 [Vi… | 2006 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091001 | Myrian 1.4 | 2009 | 7 |
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 16 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 11 of the 37 ancestors have a recall of any class.
- Of its descendants, K091001 (Intrasense, 2009) has gone furthest, with 7 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. 2007, 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?
Mydan is a multi modality medical diagnostic device It is aimed at reviewing and analysing 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 volumes of interest This device is not indicated for mammography use.…
Read the full statement (117 words)
Mydan is a multi modality medical diagnostic device It is aimed at reviewing and analysing 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 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/K071000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071000: Myrian.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071000
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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