510(k) · Cleared

Cleared

Imt.Lab Software

K062598510(k) TraditionalCleared Oct 31, 200660-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

Esaote Europe B.V. · LLZ System, Image Processing, Radiological

Cleared on Oct 31, 2006 as substantially equivalent to K043360 (Pie Medical, 2005) and 2 other predicates after a 60-day review. Its family tree reaches back 3 generations to 2002.

Decided: Oct 31, 2006
Review: 60 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K021966 (2002). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK021966 Q Lab SoftwareAdvanced Technology Laboratories, Inc. · 2002
2 generations backK030223 SonocalcSonometric Health, LLC · 2003 · Recalled
1 generation backK043360 Imt.LabPie Medical · 2005
This deviceK062598 Imt.Lab SoftwareEsaote Europe B.V. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K021966	Q Lab Software	Advanced Technology Laboratories, Inc.	2002	—
−2	K030223	Sonocalc	Sonometric Health, LLC	2003	1
−1	K043360	Imt.Lab	Pie Medical	2005	—
0 (this device)	K062598	Imt.Lab Software	Esaote Europe B.V.	2006	—

FIG. 1 — Lineage of K062598, 2002–2006Source: 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? (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
*	K043360	Imt.Lab Summary page 1 …lassification Number: 90 LLZ 807,92(a)(3) Predicate Device(s) Esaote Europe IMT.LAB K043360 SonoMetric Health SonoCalc K030223 Phillips QLAB…	Pie Medical	2005	—
*	K030223	Sonocalc Summary page 1 …Predicate Device(s) Esaote Europe IMT.LAB K043360 SonoMetric Health SonoCalc K030223 Phillips QLAB K021966 Additional Substantial Equivalence Information is pr…	Sonometric Health, LLC	2003	1
*	K021966	Q Lab Software Summary page 1 …K043360 SonoMetric Health SonoCalc K030223 Phillips QLAB K021966 Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.…	Advanced Technology Laboratories, Inc.	2002	—

Also cleared against K043360: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 4 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
1 of the 3 ancestors has a recall of any class.
2 other devices also cite its predicate K043360.

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?

The IMT.LAB software is a Windows 2000/XP software application package to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote ultrasound systems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062598 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062598: Imt.Lab Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062598

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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