510(k) · Cleared

Cleared

CAAS

K052988510(k) TraditionalCleared Dec 30, 200567-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 Dec 30, 2005 as substantially equivalent to K945540 (Pie Medical Equipment B.V., 1995) and 3 other predicates after a 67-day review. Its family tree reaches back 3 generations to 1992. 5 of the 51 devices in its family, counting itself, have a Class I recall. 43 later devices descend from it.

Decided: Dec 30, 2005
Review: 67 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K922804 (1992). 7 ancestors in all. 43 later devices descend from it, 8 citing it directly. 5 of the 51 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK922804 Awos Angiographic WorkstationSiemens Medical Solutions USA, Inc. · 1992
2 generations backK982203 Caas II Lva Biplane OptionPie Medical Equipment B.V. · 1998
1 generation backK033920 Caas II RvaPie Medical Imaging BV · 2004
This deviceK052988 CAASPie Medical Imaging BV · 2005
Descendant · cites it directly · 39 of its ownK063344 Caas Qca 3DPie Medical Imaging BV · 2006
Descendant · 2 generations on · 38 of its ownK072591 Cardiop-B System, Version 2.1Paieon, Inc. · 2007
Descendant · cites it directly · 37 of its ownK073328 Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008
Descendant · cites it directly · 36 of its ownK082907 IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008
Descendant · 2 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2006high 6 (2012) · low 0 (2020)2026

Class I recalls in this family

K190106 Intra-Operative Positioning System; Simple Curve…5 generations on · 2019
K242133 Intra-Operative Positioning System (IOPS®)…6 generations on · 2024
K241243 Intra-Operative Positioning System (IOPS®)…6 generations on · 2024
K230309 Intra-Operative Positioning System (IOPS®)…6 generations on · 2023

Most influential descendants

Showing 5 of 43 · See all

K063344Caas Qca 3DPie Medical Imaging BV · 2006 · cites it directly39descendants
K072591Cardiop-B System, Version 2.1Paieon, Inc. · 2007 · 2 generations on38descendants
K073328Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008 · cites it directly37descendants
K082907IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008 · cites it directly36descendants
K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 2 generations on30descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K922804	Awos Angiographic Workstation	Siemens Medical Solutions USA, Inc.	1992	—
−2	K982203	Caas II Lva Biplane Option	Pie Medical Equipment B.V.	1998	—
−1	K033920	Caas II Rva	Pie Medical Imaging BV	2004	—
0 (this device)	K052988	CAAS	Pie Medical Imaging BV	2005	—
+1	K063344	Caas Qca 3D	Pie Medical Imaging BV	2006	—
+2	K072591	Cardiop-B System, Version 2.1	Paieon, Inc.	2007	—
+1	K073328	Cardiop-B System, Version 2.1 with Lva	Paieon, Inc.	2008	—
+1	K082907	IC-Pro System, Version 3.1.0.4	Paieon, Inc.	2008	—
+2	K083745	The IC-Pro System, Model Version 3.2	Paieon, Inc.	2009	—

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
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

FIG. 1 — Lineage of K052988, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K945540	Caas II Summary page 1 …System (LLZ). The above as stated in 21 CFR, part 892.1570, has been classified as regulatory Class I[. The CAAS software package is substantially equivalent to: * K945540 CAAS II K982203 CAAS If LVA biplane * K012475 CAAS 1[ QVA K033920 CAAS II RVA CAAS is a new generation of CAAS medical d…	Pie Medical Equipment B.V.	1995	—
*	K982203	Caas II Lva Biplane Option Summary page 1 …above as stated in 21 CFR, part 892.1570, has been classified as regulatory Class I[. The CAAS software package is substantially equivalent to: * K945540 CAAS II K982203 CAAS If LVA biplane * K012475 CAAS 1[ QVA K033920 CAAS II RVA CAAS is a new generation of CAAS medical device software that…	Pie Medical Equipment B.V.	1998	—
*	K012475	Caas II Qva Summary page 1 …rt 892.1570, has been classified as regulatory Class I[. The CAAS software package is substantially equivalent to: * K945540 CAAS II K982203 CAAS If LVA biplane * K012475 CAAS 1[ QVA K033920 CAAS II RVA CAAS is a new generation of CAAS medical device software that includes and elaborates on…	Pie Medical Imaging BV	2001	—
*	K033920	Caas II Rva Summary page 1 …assified as regulatory Class I[. The CAAS software package is substantially equivalent to: * K945540 CAAS II K982203 CAAS If LVA biplane * K012475 CAAS 1[ QVA K033920 CAAS II RVA CAAS is a new generation of CAAS medical device software that includes and elaborates on…	Pie Medical Imaging BV	2004	—

Also cleared against K945540: 1 other device →

What descends from it? (43)

See all 43

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063344	Caas Qca 3D	Pie Medical Imaging BV	2006	39
K073328	Cardiop-B System, Version 2.1 with Lva	Paieon, Inc.	2008	37
K082907	IC-Pro System, Version 3.1.0.4	Paieon, Inc.	2008	36
K100292	Caas Qva 3D, Caas Qca 3D	Pie Medical Imaging BV	2010	13
K133993	Caas Workstation	Pie Medical Imaging	2014	10
K180019	CAAS Workstation	Pie Medical Imaging BV	2018	8
K112807	X-Ray Vva	Medis Medical Imaging Systems BV	2012	2
K143044	CAAS A-Valve	Pie Medical Imaging BV	2015	0

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 · 5 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 · 6 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 · 6 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 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
1 of the 7 ancestors has a recall of any class.
Of its descendants, K063344 (Pie Medical Imaging BV, 2006) has gone furthest, with 39 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

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

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

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

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?

CAL Calculate the pixel size of the image to be analyzed MEAS Perform basic length, angle and density measurements. QCA Detect the contour of the coronary vessel in the angiographic X-ray image - Generate absolute measurements about the dimensions of the coronary artery segment. QVA Detect the contour of the peripheral vessel in the angiographic X-ray image - Generate absolute measurements about the dimensions of the peripheral vessel segment. LVA…

Read the full statement (172 words)

CAL

Calculate the pixel size of the image to be analyzed

MEAS

Perform basic length, angle and density measurements.

QCA

Detect the contour of the coronary vessel in the angiographic X-ray image - Generate absolute measurements about the dimensions of the coronary artery segment.

QVA

Detect the contour of the peripheral vessel in the angiographic X-ray image - Generate absolute measurements about the dimensions of the peripheral vessel segment.

LVA biplane

Delineate the outline of the left ventricular wall automatically and/or manually in angiographic X-ray images - either monoplane or biplane analysis; absolute measurements of left ventricular volumes based on several established models for children and adults - calculations of derived parameters; quantification of the motion of the right ventricular wall.

RVA

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/K052988 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052988: CAAS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052988

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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