510(k) · Cleared
ClearedArterys Cardio DL
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 Jan 5, 2017 as substantially equivalent to K162513 (Arterys, Inc., 2016) and 1 other predicate after a 48-day review. Its family tree reaches back 7 generations to 1994. 4 later devices descend from it.
- Decided
- Jan 5, 2017
- Review
- 48 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K940172 (1994). 25 ancestors in all, the oldest K871859 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 6 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 5 generations backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- 4 generations backK031927 GE Delta Software Option for MriGE Medical Systems · 2003
- 3 generations backK121762 Cardiac VXGe Medical Systems, LLC · 2013 · Recalled
- 2 generations backK140587 MR-CT VvaMedis Medical Imaging Systems BV · 2015
- 1 generation backK162513 Arterys Software v2.0Arterys, Inc. · 2016
- This deviceK163253 Arterys Cardio DLArterys, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK182034 Arterys MICAArterys, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK192437 Arterys MICAArterys, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK203744 Arterys MICAArterys, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK252539 Tempus PixelArterys, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −6 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −5 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| −4 | K031927 | GE Delta Software Option for Mri | GE Medical Systems | 2003 | — |
| −3 | K121762 | Cardiac VX | Ge Medical Systems, LLC | 2013 | 1 |
| −2 | K140587 | MR-CT Vva | Medis Medical Imaging Systems BV | 2015 | — |
| −1 | K162513 | Arterys Software v2.0 | Arterys, Inc. | 2016 | — |
| 0 (this device) | K163253 | Arterys Cardio DL | Arterys, Inc. | 2017 | — |
| +1 | K182034 | Arterys MICA | Arterys, Inc. | 2018 | — |
| +2 | K192437 | Arterys MICA | Arterys, Inc. | 2020 | — |
| +3 | K203744 | Arterys MICA | Arterys, Inc. | 2022 | — |
| +4 | K252539 | Tempus Pixel | Arterys, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K162513 | Arterys Software v2.0Summary page 4…lass II 3. Predicate Device Primary Predicate Device: Proprietary Name Arterys Software v2.0 Premarket Notification K162513 Classification Name System, Image Processing, Radiological Regulation Number 21 CFR 892.2050 Pr… | 2016 |
| * | K140587 | MR-CT VvaSummary page 4…LLZ Regulatory Class II Secondary Predicate Device: Proprietary Name Medis Imaging QMass Premarket Notification K140587 Classification Name System, Image Processing, Radiological Regulation Number 21 CFR 892.2050 Pr… | 2015 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182034 | Arterys MICA | 2018 | 3 |
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 23 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 8 of the 25 ancestors have a recall of any class.
- Of its descendants, K182034 (Arterys, Inc., 2018) has gone furthest, with 3 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. 2017, 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 Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners.…
Read the full statement (133 words)
Arterys Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by Arterys Cardio DL is intended to be used to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
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/K163253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163253: Arterys Cardio DL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163253
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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