510(k) · Cleared
ClearedQuantitative Vascular Angiography - CMS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medis Medical Imaging Systems BV · IZI System, X-Ray, Angiographic
Cleared on Jan 24, 2003 as substantially equivalent to K993763 (Medis Medical Imaging Systems BV, 1999) after a 56-day review. Its family tree reaches back 2 generations to 1994. 6 later devices descend from it.
- Decided
- Jan 24, 2003
- Review
- 56 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940172 (1994). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 1 generation backK993763 Quantitative Analysis of Coronary Angiograms (Qca)Medis Medical Imaging Systems BV · 1999
- This deviceK023970 Quantitative Vascular Angiography - CMSMedis Medical Imaging Systems BV · 2003
- Descendant · cites it directly · 2 of its ownK112807 X-Ray VvaMedis Medical Imaging Systems BV · 2012
- Descendant · cites it directly · 2 of its ownK034059 Sectra Angiography Package and Sectra Cardiology PackageSectra AB · 2004
- Descendant · 2 generations on · 1 of its ownK222036 MPXA-2000Medipixel, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK042781 Ipacs CardioRealtimeimage, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK252634 Imagine® Enterprise SuiteSoftlink International Private Limited · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K112807X-Ray VvaMedis Medical Imaging Systems BV · 2012 · cites it directly2descendants
- K034059Sectra Angiography Package and Sectra Cardiology PackageSectra AB · 2004 · cites it directly2descendants
- K222036MPXA-2000Medipixel, Inc. · 2023 · 2 generations on1descendant
- K042781Ipacs CardioRealtimeimage, Inc. · 2004 · 2 generations on1descendant
- K252634Imagine® Enterprise SuiteSoftlink International Private Limited · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −1 | K993763 | Quantitative Analysis of Coronary Angiograms (Qca) | Medis Medical Imaging Systems BV | 1999 | — |
| 0 (this device) | K023970 | Quantitative Vascular Angiography - CMS | Medis Medical Imaging Systems BV | 2003 | — |
| +1 | K112807 | X-Ray Vva | Medis Medical Imaging Systems BV | 2012 | — |
| +1 | K034059 | Sectra Angiography Package and Sectra Cardiology Package | Sectra AB | 2004 | — |
| +2 | K222036 | MPXA-2000 | Medipixel, Inc. | 2023 | — |
| +2 | K042781 | Ipacs Cardio | Realtimeimage, Inc. | 2004 | — |
| +3 | K252634 | Imagine® Enterprise Suite | Softlink International Private Limited | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 IZI? 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K993763 | Quantitative Analysis of Coronary Angiograms (Qca)Summary page 1…ame: QVA-CMS Device Class. Name: System, X-ray, Angiographic Regulation Number: 21 CFR 892.1600 (90 IZI; Class II) 3) Predicate Device: QCA-CMS; 510(k) K993763 4) Device Description: QVA-CMS is a state-of-the-art analytical software tool designed for Windows operating systems. QVA-CMS an… | 1999 |
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 9 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K112807 (Medis Medical Imaging Systems BV, 2012) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K993763.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
QVA-CMS is developed for the quantitative analysis of vascular morphology in peripheral arteries and is applicable in both research studies and during interventions in the vascular lab. The automated contour detection can be used to standard digital, subtracted and inverted images. The package reduces significantly the intra- and inter-observer variability associated with conventional visual assessment. It also avoids the very time-consuming conventional…
Read the full statement (103 words)
QVA-CMS is developed for the quantitative analysis of vascular morphology in peripheral arteries and is applicable in both research studies and during interventions in the vascular lab. The automated contour detection can be used to standard digital, subtracted and inverted images. The package reduces significantly the intra- and inter-observer variability associated with conventional visual assessment. It also avoids the very time-consuming conventional manual tracing of boundaries.
QVA-CMS analytical software is intended to support clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the assessment of X-ray images. When interpreted by trained physicians these parameters may be useful in supporting a clinical decision process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023970: Quantitative Vascular Angiography - CMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023970
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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