510(k) Report

510(k) · Cleared

Cleared

Caas II Qva

K012475510(k) TraditionalCleared Oct 24, 200183-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pie Medical Imaging BV · LLZ System, Image Processing, Radiological

Cleared on Oct 24, 2001 as substantially equivalent to K945540 (Pie Medical Equipment B.V., 1995) after an 83-day review. Its family tree reaches back 1 generation to 1995. 5 of the 46 devices in its family, counting itself, have a Class I recall. 44 later devices descend from it.

Decided
Oct 24, 2001
Review
83 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K945540 (1995). 44 later devices descend from it, 1 citing it directly. 5 of the 46 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2005: 1 descendant cleared2006: 1 descendant cleared2012: 6 descendants cleared2018: 1 descendant cleared2008: 2 descendants cleared2015: 2 descendants cleared2014: 3 descendants cleared2010: 2 descendants cleared2007: 1 descendant cleared2009: 3 descendants cleared2023: 4 descendants cleared, 1 with a Class I recall12016: 2 descendants cleared2024: 3 descendants cleared, 2 with a Class I recall22025: 4 descendants cleared, 1 with a Class I recall12019: 2 descendants cleared, 1 with a Class I recall12011: 1 descendant cleared2013: 1 descendant cleared2021: 1 descendant cleared2026: 3 descendants cleared2017: 1 descendant clearedK945540 · Caas II · Pie Medical Equipment B.V. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 8 descendants3 generations forward: 9 descendants4 generations forward: 8 descendants5 generations forward: 7 descendants6 generations forward: 4 descendants, 1 with a Class I recall17 generations forward: 5 descendants, 4 with a Class I recall48 generations forward: 2 descendants K945540 · Caas II · Pie Medical Equipment B.V. · 19950+5
  1. Root · 1 generation backK945540 Caas IIPie Medical Equipment B.V. · 1995
  2. This deviceK012475 Caas II QvaPie Medical Imaging BV · 2001
  3. Descendant · cites it directly · 43 of its ownK052988 CAASPie Medical Imaging BV · 2005
  4. Descendant · 2 generations on · 39 of its ownK063344 Caas Qca 3DPie Medical Imaging BV · 2006
  5. Descendant · 3 generations on · 38 of its ownK072591 Cardiop-B System, Version 2.1Paieon, Inc. · 2007
  6. Descendant · 2 generations on · 37 of its ownK073328 Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008
  7. 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

2005: 12006: 12007: 12008: 22009: 32010: 22011: 12012: 62013: 12014: 32015: 22016: 22017: 12018: 12019: 22021: 12023: 42024: 32025: 42026: 3
2005high 6 (2012) · low 0 (2020)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
−1K945540Caas IIPie Medical Equipment B.V.1995—
0 (this device)K012475Caas II QvaPie Medical Imaging BV2001—
+1K052988CAASPie Medical Imaging BV2005—
+2K063344Caas Qca 3DPie Medical Imaging BV2006—
+3K072591Cardiop-B System, Version 2.1Paieon, Inc.2007—
+2K073328Cardiop-B System, Version 2.1 with LvaPaieon, Inc.2008—
+2K082907IC-Pro System, Version 3.1.0.4Paieon, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200820
200930
201020
201110
201260
201310
201430
201520
201620
201710
201810
201921
202110
202341
202432
202541
202630
FIG. 1 — Lineage of K012475, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K945540Caas II
Summary page 1
…570, has been classified as regulatory Class I1. The CAAS II QVA software packaée is substantially equivalent to the CAAS II QCA software package known under FDA number K945540. The CAAS I QVA is one of the software modules intended to run on the Cardiovascular Angiography Analysis System mark II, CAAS I…
Pie Medical Equipment B.V.1995—

Also cleared against K945540: 1 other device →

What descends from it? (44)

See all 44

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K052988CAASPie Medical Imaging BV200543

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?

  • Its one ancestor has no recall.
  • 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 K945540.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

1. Optimizing the quantitation of artery dimensions - to be used in clinical trials and in clinical cath lab environment

2. Managing of data resulting of the analysis of artery dimensions

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K945540

1 other device cites the same predicate.

  • K052988CAASPie Medical Imaging BV · 2005

More from Pie Medical Imaging BV

23 FDA decisions under this applicant name. See the company

  • K2503303mensio WorkstationPie Medical Imaging BV · 20251 recall
  • K232147CAAS WorkstationPie Medical Imaging BV · 2024
  • K232007CAAS MR SolutionsPie Medical Imaging BV · 2024
  • K212376Caas QardiaPie Medical Imaging BV · 2022
  • K181825CAAS MR SolutionsPie Medical Imaging BV · 2018

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K012475 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012475: Caas II Qva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012475

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026