510(k) · Cleared
ClearedImt.Lab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pie Medical · LLZ System, Image Processing, Radiological
Cleared on Jan 5, 2005 as substantially equivalent to K030223 (Sonometric Health, LLC, 2003) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 2002. 22 later devices descend from it.
- Decided
- Jan 5, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021966 (2002). 22 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK021966 Q Lab SoftwareAdvanced Technology Laboratories, Inc. · 2002
- 1 generation backK030223 SonocalcSonometric Health, LLC · 2003 · Recalled
- This deviceK043360 Imt.LabPie Medical · 2005
- Descendant · cites it directly · 18 of its ownK061961 Art Lab SoftwarePie Medical · 2006
- Descendant · 2 generations on · 12 of its ownK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016
- Descendant · 3 generations on · 9 of its ownK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled
- Descendant · 4 generations on · 8 of its ownK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018
- Descendant · 5 generations on · 4 of its ownK230179 6440 MyLabX90Esaote, S.p.A. · 2023 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K061961Art Lab SoftwarePie Medical · 2006 · cites it directly18descendants
- K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016 · 2 generations on12descendants
- K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · 3 generations on9descendants
- K1732916440 Ultrasound SystemEsaote, S.p.A. · 2018 · 4 generations on8descendants
- K2301796440 MyLabX90Esaote, S.p.A. · 2023 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021966 | Q Lab Software | Advanced Technology Laboratories, Inc. | 2002 | — |
| −1 | K030223 | Sonocalc | Sonometric Health, LLC | 2003 | 1 |
| 0 (this device) | K043360 | Imt.Lab | Pie Medical | 2005 | — |
| +1 | K061961 | Art Lab Software | Pie Medical | 2006 | — |
| +2 | K153277 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2016 | — |
| +3 | K163082 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2017 | 2 |
| +4 | K173291 | 6440 Ultrasound System | Esaote, S.p.A. | 2018 | — |
| +5 | K230179 | 6440 MyLabX90 | Esaote, S.p.A. | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K030223 | SonocalcSummary page 1…lassification Number: 90 LLZ 807.92(a)(3) Predicate Device(s) SonoMetric Health SonoCalc K030223 Phillips QLAB K021966 Additional Substantial Equivalence Information is pr… | 2003 |
| * | K021966 | Q Lab SoftwareSummary page 1…Predicate Device(s) SonoMetric Health SonoCalc K030223 Phillips QLAB K021966 Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.… | 2002 |
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K061961 (Pie Medical, 2006) has gone furthest, with 18 descendants of its own.
- 5 other devices also cite its predicate K030223.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 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 Pie ultrasound systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043360 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043360: Imt.Lab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043360
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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