510(k) · Cleared
ClearedCaas Qva 3D, Caas Qca 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pie Medical Imaging BV · LLZ System, Image Processing, Radiological
Cleared on Apr 30, 2010 as substantially equivalent to K052988 (Pie Medical Imaging BV, 2005) and 2 other predicates after an 87-day review. Its family tree reaches back 11 generations to 1993. 1 of the 80 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.
- Decided
- Apr 30, 2010
- Review
- 87 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K926514 (1993). 66 ancestors in all, the oldest K882061 (1988). 13 later devices descend from it, 2 citing it directly. 1 of the 80 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 7 generations between
- 3 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- This deviceK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
- Descendant · cites it directly · 10 of its ownK133993 Caas WorkstationPie Medical Imaging · 2014
- Descendant · 2 generations on · 9 of its ownK151780 CAAS WorkstationPie Medical Imaging BV · 2016
- Descendant · 3 generations on · 8 of its ownK180019 CAAS WorkstationPie Medical Imaging BV · 2018
- Descendant · 4 generations on · 4 of its ownK182611 Qangio XA 3DMedis Medical Imaging Systems BV · 2019
- Descendant · 5 generations on · 2 of its ownK210093 AccuFFRangioArteryFlow Technology Co., Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 10 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 9 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 8 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 7 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 6 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 5 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 4 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 3 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- This deviceK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…9 generations back · 2003
Most influential descendants
Showing 5 of 13 · See all- K133993Caas WorkstationPie Medical Imaging · 2014 · cites it directly10descendants
- K151780CAAS WorkstationPie Medical Imaging BV · 2016 · 2 generations on9descendants
- K180019CAAS WorkstationPie Medical Imaging BV · 2018 · 3 generations on8descendants
- K182611Qangio XA 3DMedis Medical Imaging Systems BV · 2019 · 4 generations on4descendants
- K210093AccuFFRangioArteryFlow Technology Co., Ltd. · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −10 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −9 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −8 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −7 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −6 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −5 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −4 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −3 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −2 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −1 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| 0 (this device) | K100292 | Caas Qva 3D, Caas Qca 3D | Pie Medical Imaging BV | 2010 | — |
| +1 | K133993 | Caas Workstation | Pie Medical Imaging | 2014 | — |
| +2 | K151780 | CAAS Workstation | Pie Medical Imaging BV | 2016 | — |
| +3 | K180019 | CAAS Workstation | Pie Medical Imaging BV | 2018 | — |
| +4 | K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | 2019 | — |
| +5 | K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 8 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 1 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 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 |
|---|---|---|---|
| * | K052988 | CAASSummary page 1…CAAS QCA 3D GAAS QVA 3D Regulation Class Class II1(21 CER, part 892.2050, LLZ) Predicate Devices CAAS, cleared for marketing under K052988 CAAS QCA 3D, cleared for marketing under K063344 IC-Pro, cleared under K083745 Device… | 2005 |
| * | K063344 | Caas Qca 3DSummary page 1…s Class II1(21 CER, part 892.2050, LLZ) Predicate Devices CAAS, cleared for marketing under K052988 CAAS QCA 3D, cleared for marketing under K063344 IC-Pro, cleared under K083745 Device Description The CAAS QxA 3D covers the QCA 3D and QVA 3D software mo… | 2006 |
| * | K083745 | The IC-Pro System, Model Version 3.2Summary page 1…ate Devices CAAS, cleared for marketing under K052988 CAAS QCA 3D, cleared for marketing under K063344 IC-Pro, cleared under K083745 Device Description The CAAS QxA 3D covers the QCA 3D and QVA 3D software modules intended to run on the C… | 2009 |
What descends from it? (13)
See all 132 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 · 9 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 17 of the 66 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K133993 (Pie Medical Imaging, 2014) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K052988.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
CMAS QxA 3D is used for: 1. 3D Reconstruction of coronary arteries and peripheral vessels from a set of angiographic X-ray images; 2. Calculation of dimensions of the vessel corrected for out-of-plane magnification and foreshortening errors; 3. To determine acquisition parameters for optimal imaging of part of interest on a vessel tree; 4. To assist in the positioning of implantable devices in the vessel segment of interest. The CAAS QxA 3D software is…
Read the full statement (111 words)
CMAS QxA 3D is used for:
1. 3D Reconstruction of coronary arteries and peripheral vessels from a set of angiographic X-ray images;
2. Calculation of dimensions of the vessel corrected for out-of-plane magnification and foreshortening errors;
3. To determine acquisition parameters for optimal imaging of part of interest on a vessel tree;
4. To assist in the positioning of implantable devices in the vessel segment of interest.
The CAAS QxA 3D software is designed for use in clinical practice to support diagnoses and interventional treatment of cardiovascular conditions. The software is used by or under supervision of a cardiologist or radiologist.
CAAS OCA 3D: coronary arteries
CAAS QVA 3D: peripheral vessels
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100292: Caas Qva 3D, Caas Qca 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100292
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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