510(k) · Cleared
ClearedAV Vascular
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · QIH Automated Radiological Image Processing Software
Cleared on Jan 22, 2026 as substantially equivalent to K153736 (Pie Medical Imaging BV, 2016) and 1 other predicate after a 59-day review. Its family tree reaches back 12 generations to 1997. 3 of the 139 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 22, 2026
- Review
- 59 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K971684 (1997). 138 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet. 3 of the 139 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations between
- 3 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 2 generations backK130749 Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013
- 1 generation backK203216 The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V. · 2020
- This deviceK253735 AV VascularPhilips Medical Systems Nederland B.V. · 2026
Show all 12 generations
- Root · 12 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 11 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 10 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 9 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 8 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 7 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 6 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 5 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 4 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 3 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 2 generations backK130749 Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013
- 1 generation backK203216 The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V. · 2020
- This deviceK253735 AV VascularPhilips Medical Systems Nederland B.V. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −11 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −10 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −9 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −8 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −7 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −6 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −5 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −4 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −3 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −2 | K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −1 | K203216 | The Multimodality Advanced Vessel Analysis | Philips Medical Systems Nederland B.V. | 2020 | — |
| 0 (this device) | K253735 | AV Vascular | Philips Medical Systems Nederland B.V. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 14 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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.
3 devices in this family have a Class I recall. 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K153736 | 3mensio WorkstationSummary page 5…ssification 21 CFR 892.2050 Primary Predicate Device Pie Medical Imaging’s 3mensio Structural Heart / 3mensio Vascular (K153736) Secondary Predicate Philips Medical Systems’ The Multimodality Advanced Vessel Analysis Device… | 2016 |
| * | K203216 | The Multimodality Advanced Vessel AnalysisSummary page 5…(K153736) Secondary Predicate Philips Medical Systems’ The Multimodality Advanced Vessel Analysis Device (MM AVA) application (K203216) Reference Device Philips Medical Systems’ Spectral CT Applications (K150665) Device Description AV Vascu… | 2020 |
| † | K150665 | Philips Spectral CT Applications | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 5 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 35 of the 138 ancestors have a recall of any class; 3 have a Class I recall.
- 10 other devices also cite its predicate K153736.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
AV Vascular is indicated to assist users in the visualization, assessment and quantification of vascular anatomy on CTA and/or MRA datasets, in order to assess patients with suspected or diagnosed vascular pathology and to assist with pre-procedural planning of endovascular interventions.
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/K253735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253735: AV Vascular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253735
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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