510(k) · Cleared

Cleared

Quantitative Analysis of Coronary Angiograms (Qca)

K993763510(k) SpecialCleared Nov 26, 199918-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

Medis Medical Imaging Systems BV · IZI System, X-Ray, Angiographic

Cleared on Nov 26, 1999 as substantially equivalent to K940172 (Medis Medical Imaging Systems, Inc., 1994) after an 18-day review. Its family tree reaches back 1 generation to 1994. 5 of the 50 devices in its family, counting itself, have a Class I recall. 48 later devices descend from it.

Decided: Nov 26, 1999
Review: 18 days
Class: Class II
Product code: IZI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K940172 (1994). 48 later devices descend from it, 5 citing it directly. 5 of the 50 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
This deviceK993763 Quantitative Analysis of Coronary Angiograms (Qca)Medis Medical Imaging Systems BV · 1999
Descendant · cites it directly · 40 of its ownK030139 The Cardiop-B SystemPaieon, Inc. · 2004
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 · 2 generations on · 31 of its ownK060483 Volcano Angio-Ivus Mapping (Aim) SystemVolcano Corporation · 2006

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2003high 6 (2012) · low 0 (2005)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 48 · See all

K030139The Cardiop-B SystemPaieon, Inc. · 2004 · cites it directly40descendants
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
K060483Volcano Angio-Ivus Mapping (Aim) SystemVolcano Corporation · 2006 · 2 generations on31descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940172	Cardiovascular Measurement System-CMS	Medis Medical Imaging Systems, Inc.	1994	—
0 (this device)	K993763	Quantitative Analysis of Coronary Angiograms (Qca)	Medis Medical Imaging Systems BV	1999	—
+1	K030139	The Cardiop-B System	Paieon, Inc.	2004	—
+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	—
+2	K060483	Volcano Angio-Ivus Mapping (Aim) System	Volcano Corporation	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	3	0
2006	1	0
2007	1	0
2008	3	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 K993763, 1994–2026Source: 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? (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	Applicant	Decided	Recalls
*	K940172	Cardiovascular Measurement System-CMS Summary page 1 …: System, X-ray, Angiographic; Regulation Number 21 CFR 892.1600 (90 I1ZI; Class II) 3) Predicate Device(s) : Cardiovascular Measurement System - (CMS) 510(k) Number: K940172 4) Description of the device: QCA-CMS performs quantitative analysis of angiograms that are input to the system in formats that…	Medis Medical Imaging Systems, Inc.	1994	—

Also cleared against K940172: 1 other device →

What descends from it? (48)

See all 48

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

Number	Device	Applicant	Decided	Descendants
K030139	The Cardiop-B System	Paieon, Inc.	2004	40
K072591	Cardiop-B System, Version 2.1	Paieon, Inc.	2007	38
K023970	Quantitative Vascular Angiography - CMS	Medis Medical Imaging Systems BV	2003	6
K112807	X-Ray Vva	Medis Medical Imaging Systems BV	2012	2
K034059	Sectra Angiography Package and Sectra Cardiology Package	Sectra AB	2004	2

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, K030139 (Paieon, Inc., 2004) has gone furthest, with 40 descendants of its own.
1 other device also cites its predicate K940172.

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?

QCA-CMS provides quantitative and reproducible information regarding the calculated

dimensions of arterial segments imaged during angiographic x-ray procedures typically

performed in cardiac cath labs. This information is suitable for use by physicians and

scientists in the following applications:

1. Scientific and research studies, assessing the angiographic condition of patients and

the results of device and drug therapies,

2. Review and analysis of patient angiographic imaging records, providing additional

information to physicians and administrators.

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/K993763 · printed Nov 5, 2026

Cite this page

510(k) Report. “K993763: Quantitative Analysis of Coronary Angiograms (Qca).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993763

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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