510(k) · Cleared
ClearedCaas 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 Nov 28, 2006 as substantially equivalent to K052988 (Pie Medical Imaging BV, 2005) after a 22-day review. Its family tree reaches back 4 generations to 1992. 5 of the 48 devices in its family, counting itself, have a Class I recall. 39 later devices descend from it.
- Decided
- Nov 28, 2006
- Review
- 22 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K922804 (1992). 8 ancestors in all. 39 later devices descend from it, 2 citing it directly. 5 of the 48 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK922804 Awos Angiographic WorkstationSiemens Medical Solutions USA, Inc. · 1992
- 3 generations backK982203 Caas II Lva Biplane OptionPie Medical Equipment B.V. · 1998
- 2 generations backK033920 Caas II RvaPie Medical Imaging BV · 2004
- 1 generation backK052988 CAASPie Medical Imaging BV · 2005
- This deviceK063344 Caas Qca 3DPie Medical Imaging BV · 2006
- Descendant · cites it directly · 38 of its ownK072591 Cardiop-B System, Version 2.1Paieon, Inc. · 2007
- Descendant · 2 generations on · 37 of its ownK073328 Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008
- Descendant · 3 generations on · 36 of its ownK082907 IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008
- Descendant · 4 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- Descendant · 5 generations on · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190106 Intra-Operative Positioning System; Simple Curve…7 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…8 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…8 generations on · 2024
- K230309 Intra-Operative Positioning System (IOPS®)…8 generations on · 2023
Most influential descendants
Showing 5 of 39 · See all- K072591Cardiop-B System, Version 2.1Paieon, Inc. · 2007 · cites it directly38descendants
- K073328Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008 · 2 generations on37descendants
- K082907IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008 · 3 generations on36descendants
- K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 4 generations on30descendants
- K110256The IC-Pro SystemPaieon, Inc. · 2011 · 5 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922804 | Awos Angiographic Workstation | Siemens Medical Solutions USA, Inc. | 1992 | — |
| −3 | K982203 | Caas II Lva Biplane Option | Pie Medical Equipment B.V. | 1998 | — |
| −2 | K033920 | Caas II Rva | Pie Medical Imaging BV | 2004 | — |
| −1 | K052988 | CAAS | Pie Medical Imaging BV | 2005 | — |
| 0 (this device) | K063344 | Caas Qca 3D | Pie Medical Imaging BV | 2006 | — |
| +1 | K072591 | Cardiop-B System, Version 2.1 | Paieon, Inc. | 2007 | — |
| +2 | K073328 | Cardiop-B System, Version 2.1 with Lva | Paieon, Inc. | 2008 | — |
| +3 | K082907 | IC-Pro System, Version 3.1.0.4 | Paieon, Inc. | 2008 | — |
| +4 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| +5 | K110256 | The IC-Pro System | Paieon, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 1 |
| 2021 | 1 | 0 |
| 2023 | 3 | 1 |
| 2024 | 3 | 2 |
| 2025 | 4 | 1 |
| 2026 | 2 | 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.
5 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 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? (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 |
|---|---|---|---|
| * | K052988 | CAASSummary page 1…1 CFR, part 892.1570, has been classified as regulatory Class II. The CAAS QCA 3D software package is substantially equivalent to the CAAS system known under FDA number K052988. The CAAS QCA 3D is one of the software modules intended to run on the Cardiovascular Angiography Analysis System mark, CAAS. I… | 2005 |
What descends from it? (39)
See all 392 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 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.
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 8 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 8 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 8 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K072591 (Paieon, Inc., 2007) has gone furthest, with 38 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.
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?
Detect the contour of the coronary vessel from a set of angiographic X-ray images - Generate absolute measurements about the dimensions of the coronary arterial segment in 3D space to improve accuracy by elimination of out-of-plane and foreshortening errors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063344: 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/K063344
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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