510(k) · Cleared
ClearedCaas II Rva
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 Mar 17, 2004 as substantially equivalent to K982203 (Pie Medical Equipment B.V., 1998) after a 90-day review. Its family tree reaches back 2 generations to 1992. 5 of the 49 devices in its family, counting itself, have a Class I recall. 44 later devices descend from it.
- Decided
- Mar 17, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922804 (1992). 4 ancestors in all. 44 later devices descend from it, 1 citing it directly. 5 of the 49 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK922804 Awos Angiographic WorkstationSiemens Medical Solutions USA, Inc. · 1992
- 1 generation backK982203 Caas II Lva Biplane OptionPie Medical Equipment B.V. · 1998
- This deviceK033920 Caas II RvaPie Medical Imaging BV · 2004
- Descendant · cites it directly · 43 of its ownK052988 CAASPie Medical Imaging BV · 2005
- Descendant · 2 generations on · 39 of its ownK063344 Caas Qca 3DPie Medical Imaging BV · 2006
- Descendant · 3 generations on · 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 · 2 generations on · 36 of its ownK082907 IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190106 Intra-Operative Positioning System; Simple Curve…6 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
- K230309 Intra-Operative Positioning System (IOPS®)…7 generations on · 2023
Most influential descendants
Showing 5 of 44 · See all- K052988CAASPie Medical Imaging BV · 2005 · cites it directly43descendants
- K063344Caas Qca 3DPie Medical Imaging BV · 2006 · 2 generations on39descendants
- K072591Cardiop-B System, Version 2.1Paieon, Inc. · 2007 · 3 generations on38descendants
- K073328Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008 · 2 generations on37descendants
- K082907IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008 · 2 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922804 | Awos Angiographic Workstation | Siemens Medical Solutions USA, Inc. | 1992 | — |
| −1 | K982203 | Caas II Lva Biplane Option | Pie Medical Equipment B.V. | 1998 | — |
| 0 (this device) | K033920 | Caas II Rva | Pie Medical Imaging BV | 2004 | — |
| +1 | K052988 | CAAS | Pie Medical Imaging BV | 2005 | — |
| +2 | K063344 | Caas Qca 3D | Pie Medical Imaging BV | 2006 | — |
| +3 | K072591 | Cardiop-B System, Version 2.1 | Paieon, Inc. | 2007 | — |
| +2 | K073328 | Cardiop-B System, Version 2.1 with Lva | Paieon, Inc. | 2008 | — |
| +2 | K082907 | IC-Pro System, Version 3.1.0.4 | Paieon, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 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 | 4 | 1 |
| 2024 | 3 | 2 |
| 2025 | 4 | 1 |
| 2026 | 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.
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 |
|---|---|---|---|
| * | K982203 | Caas II Lva Biplane OptionSummary page 1…lassified as regulatory Class LI. The CAAS II RVA software package is substantially equivalent to the CAAS II LVA-Biplane Option software package known under FDA number K982203. The CAAS II RVA is oie of the software modules intended to run on the Cardiovascular Angiography Analysis System mark II, CAAS… | 1998 |
What descends from it? (44)
See all 441 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052988 | CAAS | 2005 | 43 |
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 · 6 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 · 7 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 · 7 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 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K052988 (Pie Medical Imaging BV, 2005) has gone furthest, with 43 descendants of its own.
- 1 other device also cites its predicate K982203.
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?
Delineate the outline of the right ventricular wall semi-automatically or manually in angiographic X-ray images - either monoplane or biplane analysis; absolute measurements of right ventricular volumes based on several established models for children and adults - calculations of derived parameters; quantification of the motion of the right ventricular wall.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033920: Caas II Rva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033920
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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