510(k) · Cleared
ClearedQangio XA 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medis Medical Imaging Systems BV · QHA X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Cleared on May 30, 2019 as substantially equivalent to K180019 (Pie Medical Imaging BV, 2018) after a 251-day review. Its family tree reaches back 15 generations to 1993. 1 of the 104 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- May 30, 2019
- Review
- 251 days
- Class
- Class II
- Product code
- QHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K926514 (1993). 99 ancestors in all, the oldest K882061 (1988). 4 later devices descend from it, 2 citing it directly. 1 of the 104 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 11 generations between
- 3 generations backK133993 Caas WorkstationPie Medical Imaging · 2014
- 2 generations backK151780 CAAS WorkstationPie Medical Imaging BV · 2016
- 1 generation backK180019 CAAS WorkstationPie Medical Imaging BV · 2018
- This deviceK182611 Qangio XA 3DMedis Medical Imaging Systems BV · 2019
- Descendant · cites it directly · 2 of its ownK210093 AccuFFRangioArteryFlow Technology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK243769 QFR (3.0)Qfr Solutions BV · 2025
- Descendant · 2 generations on · 0 of its ownK230303 AccuFFRangio PlusArteryFlow Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK221711 AccuICASArteryFlow Technology Co., Ltd. · 2023
Show all 15 generations
- Root · 15 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 14 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 13 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 12 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 11 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 10 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 9 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 8 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 7 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 6 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 5 generations backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- 4 generations backK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
- 3 generations backK133993 Caas WorkstationPie Medical Imaging · 2014
- 2 generations backK151780 CAAS WorkstationPie Medical Imaging BV · 2016
- 1 generation backK180019 CAAS WorkstationPie Medical Imaging BV · 2018
- This deviceK182611 Qangio XA 3DMedis Medical Imaging Systems BV · 2019
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…13 generations back · 2003
Most influential descendants
Showing 4 of 4 · See all- K210093AccuFFRangioArteryFlow Technology Co., Ltd. · 2021 · cites it directly2descendants
- K243769QFR (3.0)Qfr Solutions BV · 2025 · cites it directly0descendants
- K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd. · 2023 · 2 generations on0descendants
- K221711AccuICASArteryFlow Technology Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −14 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −13 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −12 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −11 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −10 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −9 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −8 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −7 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −6 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −5 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| −4 | K100292 | Caas Qva 3D, Caas Qca 3D | Pie Medical Imaging BV | 2010 | — |
| −3 | K133993 | Caas Workstation | Pie Medical Imaging | 2014 | — |
| −2 | K151780 | CAAS Workstation | Pie Medical Imaging BV | 2016 | — |
| −1 | K180019 | CAAS Workstation | Pie Medical Imaging BV | 2018 | — |
| 0 (this device) | K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | 2019 | — |
| +1 | K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021 | — |
| +1 | K243769 | QFR (3.0) | Qfr Solutions BV | 2025 | — |
| +2 | K230303 | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | 2023 | — |
| +2 | K221711 | AccuICAS | ArteryFlow Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 1 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 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.
1 device in this family has 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 QHA device
- #1 K251355 X1-FFRscore 14.4 · 15 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 |
|---|---|---|---|
| * | K180019 | CAAS WorkstationSummary page 4…: 21 CFR 892.1600 Classification Product Code : QHA Subsequent Product Code : LLZ Predicate Device x The Pie Medical: CAAS™ Workstation (K180019), Regulation Number : 21 CFR 892.1600. Device Description QANGIO XA 3D is the Medis software solution for the quantitative analy… | 2018 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 13 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 22 of the 99 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K210093 (ArteryFlow Technology Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K180019.
How does its category compare?
All QHA devicesQHA X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QHA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QHA
Too few QHA 510(k)s in any year since 2007 to give a median.
Recalls per year · QHA
No recall names QHA since 2007.
Adverse event reports per year · QHA
No MAUDE report names QHA since 2007.
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 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
QANGIO XA 3D is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease.
When the quantified results provided by QAngio XA 3D are used in a clinical setting on X-ray images of an individual patient. The results are only intended for use by the responsible clinicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182611: Qangio XA 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182611
Report an extraction error
Are you the manufacturer?
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