510(k) · Cleared
ClearedArterys MICA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arterys, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 17, 2018 as substantially equivalent to K171544 (Arterys, Inc., 2017) and 2 other predicates after a 79-day review. Its family tree reaches back 11 generations to 1991. 3 later devices descend from it.
- Decided
- Oct 17, 2018
- Review
- 79 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K913770 (1991). 116 ancestors in all, the oldest K871859 (1987). 3 later devices descend from it, 1 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 backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 1 generation backK173542 Arterys Oncology DLArterys, Inc. · 2018
- This deviceK182034 Arterys MICAArterys, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK192437 Arterys MICAArterys, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK203744 Arterys MICAArterys, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK252539 Tempus PixelArterys, Inc. · 2025
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 backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 1 generation backK173542 Arterys Oncology DLArterys, Inc. · 2018
- This deviceK182034 Arterys MICAArterys, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView 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 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| −1 | K173542 | Arterys Oncology DL | Arterys, Inc. | 2018 | — |
| 0 (this device) | K182034 | Arterys MICA | Arterys, Inc. | 2018 | — |
| +1 | K192437 | Arterys MICA | Arterys, Inc. | 2020 | — |
| +2 | K203744 | Arterys MICA | Arterys, Inc. | 2022 | — |
| +3 | K252539 | Tempus Pixel | Arterys, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 10 | 0 |
| 2002 | 10 | 0 |
| 2003 | 4 | 0 |
| 2004 | 11 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K171544 | Arterys ViewerSummary page 4…Product Code LLZ Regulatory Class II Predicate Devices Primary Predicate Device Arterys Viewer, K171544 Secondary Predicate Device Arterys Cardio DL, K163253 Tertiary Predicate Device Arterys Oncology DL,… | 2017 |
| * | K163253 | Arterys Cardio DLSummary page 4…II Predicate Devices Primary Predicate Device Arterys Viewer, K171544 Secondary Predicate Device Arterys Cardio DL, K163253 Tertiary Predicate Device Arterys Oncology DL, K173542 2. Device Description Arterys MICA is a… | 2017 |
| * | K173542 | Arterys Oncology DLSummary page 4…evice Arterys Viewer, K171544 Secondary Predicate Device Arterys Cardio DL, K163253 Tertiary Predicate Device Arterys Oncology DL, K173542 2. Device Description Arterys MICA is a dedicated software application used as a Digital Imaging and Communica… | 2018 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192437 | Arterys MICA | 2020 | 2 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 25 of the 116 ancestors have a recall of any class.
- Of its descendants, K192437 (Arterys, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K171544.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Arterys® MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data, with the exception of mammography. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers. Arterys MICA includes an optional Cardio AI module…
Read the full statement (223 words)
Arterys® MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data, with the exception of mammography. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers.
Arterys MICA includes an optional Cardio AI module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) images. It provides clinically relevant and reproducible, quantitative data, and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners.
Arterys MICA includes an optional Oncology Al module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions.
Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/ or diagnosis, but it does not directly generate any diagnosis or potential findings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182034: Arterys MICA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182034
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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