510(k) · Cleared
ClearedCAAS A-Valve
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 Feb 6, 2015 as substantially equivalent to K113076 (Pie Medical Imaging BV, 2012) and 1 other predicate after a 107-day review. Its family tree reaches back 13 generations to 1993. 1 of the 98 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 6, 2015
- Review
- 107 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K926514 (1993). 97 ancestors in all, the oldest K882061 (1988). No later device cites it as a predicate yet. 1 of the 98 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 9 generations between
- 3 generations backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- 2 generations backK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
- 1 generation backK113076 Caas a-ValvePie Medical Imaging BV · 2012
- This deviceK143044 CAAS A-ValvePie Medical Imaging BV · 2015
Show all 13 generations
- Root · 13 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 12 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 11 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 10 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 9 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 8 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 7 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 6 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 5 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 4 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 3 generations backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- 2 generations backK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
- 1 generation backK113076 Caas a-ValvePie Medical Imaging BV · 2012
- This deviceK143044 CAAS A-ValvePie Medical Imaging BV · 2015
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…11 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −12 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −11 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −10 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −9 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −8 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −7 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −6 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −5 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −4 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −3 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| −2 | K100292 | Caas Qva 3D, Caas Qca 3D | Pie Medical Imaging BV | 2010 | — |
| −1 | K113076 | Caas a-Valve | Pie Medical Imaging BV | 2012 | — |
| 0 (this device) | K143044 | CAAS A-Valve | Pie Medical Imaging BV | 2015 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K113076 | Caas a-ValveSummary page 4…tor [email protected] 20 October 2014 CAAS A-Valve CAAS A-Valve Class IT (21 CFR, part 892.2050, LLZ) Picture Archiving and Communications System CAAS A-Valve (K113076) CAAS (K052988) CAAS A-Valve is a stand-alone software application, intended to run on a PC with a Windows operating system. The… | 2012 |
| * | K052988 | CAASSummary page 4…[email protected] 20 October 2014 CAAS A-Valve CAAS A-Valve Class IT (21 CFR, part 892.2050, LLZ) Picture Archiving and Communications System CAAS A-Valve (K113076) CAAS (K052988) CAAS A-Valve is a stand-alone software application, intended to run on a PC with a Windows operating system. The images for ana… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 11 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 22 of the 97 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
CAAS A-Valve has been developed to support the interventionalist during or in preparation of treatment of the aortic root. Based on angiographic X-ray images an analysis is performed: To assist in C-arm projection selection to optimize visualization during treatment; To calculate dimensions of the aortic root corrected for out-of-plane magnification and foreshortening errors; To provide an objective and reproducible grading method for aortic…
Read the full statement (128 words)
CAAS A-Valve has been developed to support the interventionalist during or in preparation of treatment of the aortic root.
Based on angiographic X-ray images an analysis is performed:
To assist in C-arm projection selection to optimize visualization during treatment;
To calculate dimensions of the aortic root corrected for out-of-plane magnification and foreshortening errors;
To provide an objective and reproducible grading method for aortic regurgitation based on time versus density curves extracted from an aortogram.
The software is used by or under supervision of a cardiologist or radiologist. When the results provided by CAAS A-Valve are used in a clinical setting to support diagnoses or for assistance during intervention of cardiovascular conditions, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.
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/K143044 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143044: CAAS A-Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143044
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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