510(k) · Cleared

Cleared

IN-Vision View with Measurements Module, Model 1.0

K022940510(k) TraditionalCleared Oct 11, 200237-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

Intelligent Images Srl · LLZ System, Image Processing, Radiological

Cleared on Oct 11, 2002 as substantially equivalent to K011582 (Medis Medical Imaging Systems BV, 2001) after a 37-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.

Decided: Oct 11, 2002
Review: 37 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K941322 (1995). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK941322 Echo-ScanTomographic Tech · 1995
3 generations backK963807 Tomtec Echo-ScanTomtec Imaging Systems, Inc. · 1996
2 generations backK993394 Echo Scan, Easy ScanTomtec Imaging Systems GmbH · 1999
1 generation backK011582 Qcu Analytical Software PackageMedis Medical Imaging Systems BV · 2001
This deviceK022940 IN-Vision View with Measurements Module, Model 1.0Intelligent Images Srl · 2002
Descendant · cites it directly · 1 of its ownK041581 Compacs, Version 1.0Intelligent Images Srl · 2004
Descendant · 2 generations on · 0 of its ownK120514 CardiopacsLumedx · 2012
Descendant · cites it directly · 0 of its ownK062985 Ivus EnhancerIndec Systems, Inc. · 2006

Most influential descendants

Showing 3 of 3 · See all

K041581Compacs, Version 1.0Intelligent Images Srl · 2004 · cites it directly1descendant
K120514CardiopacsLumedx · 2012 · 2 generations on0descendants
K062985Ivus EnhancerIndec Systems, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K941322	Echo-Scan	Tomographic Tech	1995	—
−3	K963807	Tomtec Echo-Scan	Tomtec Imaging Systems, Inc.	1996	—
−2	K993394	Echo Scan, Easy Scan	Tomtec Imaging Systems GmbH	1999	—
−1	K011582	Qcu Analytical Software Package	Medis Medical Imaging Systems BV	2001	—
0 (this device)	K022940	IN-Vision View with Measurements Module, Model 1.0	Intelligent Images Srl	2002	—
+1	K041581	Compacs, Version 1.0	Intelligent Images Srl	2004	—
+2	K120514	Cardiopacs	Lumedx	2012	—
+1	K062985	Ivus Enhancer	Indec Systems, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2012	1	0

FIG. 1 — Lineage of K022940, 1995–2012Source: 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.

Planning a device in LLZ? 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? (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
*	K011582	Qcu Analytical Software Package	Medis Medical Imaging Systems BV	2001	—

Also cleared against K011582: 3 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K041581	Compacs, Version 1.0	Intelligent Images Srl	2004	1
K062985	Ivus Enhancer	Indec Systems, Inc.	2006	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 7 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K041581 (Intelligent Images Srl, 2004) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K011582.

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?

In-Vision View with Measurements Module is a software device intended to be used by qualified melcal professionals, after proper installation on an appropriate hardware platform, for retrieving, viewing, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive.

In-Vision View with Measurements Module supports JOMED DICOM files only. The software wdl not read DICOM images or loops stored using any other manufacturers' system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022940 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022940: IN-Vision View with Measurements Module, Model 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022940

Report an extraction error

Are you the manufacturer?

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