510(k) · Cleared

Cleared

Caas II Lva Biplane Option

K982203510(k) TraditionalCleared Jul 14, 199822-day reviewClass II21 CFR 892.1600

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

Pie Medical Equipment B.V. · IZI System, X-Ray, Angiographic

Cleared on Jul 14, 1998 as substantially equivalent to K945460 (Philips Medical Systems North America, Inc., 1995) and 2 other predicates after a 22-day review. Its family tree reaches back 1 generation to 1992. 5 of the 49 devices in its family, counting itself, have a Class I recall. 45 later devices descend from it.

Decided: Jul 14, 1998
Review: 22 days
Class: Class II
Product code: IZI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K922804 (1992). 3 ancestors in all. 45 later devices descend from it, 2 citing it directly. 5 of the 49 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK922804 Awos Angiographic WorkstationSiemens Medical Solutions USA, Inc. · 1992
This deviceK982203 Caas II Lva Biplane OptionPie Medical Equipment B.V. · 1998
Descendant · cites it directly · 44 of its ownK033920 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

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2004high 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 45 · See all

K033920Caas II RvaPie Medical Imaging BV · 2004 · cites it directly44descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922804	Awos Angiographic Workstation	Siemens Medical Solutions USA, Inc.	1992	—
0 (this device)	K982203	Caas II Lva Biplane Option	Pie Medical Equipment B.V.	1998	—
+1	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	—

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
2004	1	0
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

FIG. 1 — Lineage of K982203, 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 IZI device

#1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 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? (3)

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
*	K945460	Philips CD Medical Recorder, View Station, Dup[[Lication Station Summary page 1 …, part 892.1570, has been classified as regulatory Class II. The CAAS II LVA-Biplane Option is substantially equivalent to the Philips CD-Medical CDM 3500 View Station, K945460, and the Philips Integris H/HM family of angiogtaphic imaging systems, K925302, and the Siemens AWOS Angiographic Workstation, K9…	Philips Medical Systems North America, Inc.	1995	—
*	K925302	Philips Integris H/HM System Summary page 1 …iplane Option is substantially equivalent to the Philips CD-Medical CDM 3500 View Station, K945460, and the Philips Integris H/HM family of angiogtaphic imaging systems, K925302, and the Siemens AWOS Angiographic Workstation, K922804. The CAAS II LVA-Biplane Option is one of the software modules intended…	Philips Medical Systems, Inc.	1992	5
*	K922804	Awos Angiographic Workstation Summary page 1 …CD-Medical CDM 3500 View Station, K945460, and the Philips Integris H/HM family of angiogtaphic imaging systems, K925302, and the Siemens AWOS Angiographic Workstation, K922804. The CAAS II LVA-Biplane Option is one of the software modules intended to run on the Cardiovascular Angiography Analysis System…	Siemens Medical Solutions USA, Inc.	1992	—

Also cleared against K945460: 2 other devices →

What descends from it? (45)

See all 45

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

Number	Device	Applicant	Decided	Descendants
K033920	Caas II Rva	Pie Medical Imaging BV	2004	44
K052988	CAAS	Pie Medical Imaging BV	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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K033920 (Pie Medical Imaging BV, 2004) has gone furthest, with 44 descendants of its own.
2 other devices also cite its predicate K945460.

How does its category compare?

All IZI devices

IZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZI

2in 2025

2007high 7 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZI

81in 2023

2007high 111 (2014) · low 28 (2007)2026

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

Recalls per year · IZI

1in 2021

2007high 52 (2008) · low 0 (2022)2026

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

Adverse event reports per year · IZI

2,171in 2025

2007high 2,171 (2025) · low 14 (2020)2025

MAUDE reports naming product code IZI, 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	7	28	6	92
2008	6	68	52	101
2009	2	—	18	132
2010	2	—	11	252
2011	4	104	6	377
2012	1	—	6	77
2013	1	—	6	58
2014	4	111	5	123
2015	0	—	14	36
2016	1	—	7	102
2017	2	—	1	88
2018	2	—	2	49
2019	2	—	2	30
2020	1	—	2	14
2021	1	—	1	29
2022	1	—	0	265
2023	3	81	0	1,204
2024	2	—	0	1,332
2025	2	—	0	2,171
2026	2	—	1	—

What is it indicated for?

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 ventricular volumes - calculation of derived parameters; Quantification of the motion of the ventricular wall by applying several established models - Estimation of the dimensions of the myocardiac wall.

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/K982203 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982203: Caas II Lva Biplane Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982203

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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