510(k) · Cleared

Cleared

Ensite Verismo Segmentation Tool V.2.0

K101697510(k) TraditionalCleared Sep 22, 201098-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

St Jude Medical · LLZ System, Image Processing, Radiological

Cleared on Sep 22, 2010 as substantially equivalent to K051840 (St Jude Medical, 2005) after a 98-day review. Its family tree reaches back 1 generation to 2005. 29 later devices descend from it.

Decided: Sep 22, 2010
Review: 98 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K051840 (2005). 29 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK051840 Ensite Verismo SoftwareSt Jude Medical · 2005
This deviceK101697 Ensite Verismo Segmentation Tool V.2.0St Jude Medical · 2010
Descendant · cites it directly · 28 of its ownK160187 Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module…St Jude Medical · 2016
Descendant · 2 generations on · 27 of its ownK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018
Descendant · 3 generations on · 26 of its ownK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
Descendant · 4 generations on · 25 of its ownK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
Descendant · 5 generations on · 18 of its ownK201181 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac…Abbott Medical · 2020

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2016high 8 (2025) · low 0 (2017)2026

Most influential descendants

Showing 5 of 29 · See all

K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical · 2016 · cites it directly28descendants
K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018 · 2 generations on27descendants
K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott · 2018 · 3 generations on26descendants
K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott · 2018 · 4 generations on25descendants
K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemAbbott Medical · 2020 · 5 generations on18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K051840	Ensite Verismo Software	St Jude Medical	2005	—
0 (this device)	K101697	Ensite Verismo Segmentation Tool V.2.0	St Jude Medical	2010	—
+1	K160187	Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0	St Jude Medical	2016	—
+2	K172396	EnSite Velocity Cardiac Mapping System v5.2	St Jude Medical	2018	—
+3	K182644	EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping…	Abbott	2018	—
+4	K183128	EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping…	Abbott	2018	—
+5	K201181	EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System	Abbott Medical	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2018	3	0
2020	3	0
2021	2	0
2022	2	0
2023	1	0
2024	3	0
2025	8	0
2026	6	0

FIG. 1 — Lineage of K101697, 2005–2026Source: 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.

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

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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
*	K051840	Ensite Verismo Software Summary page 1 …logical characteristics of the EnSite Verismo Segmentation Tool v.2.0 are substantially equivalent to the predicate device EnSite Verismo Segmentation Tool v.1.0 (K051840). 12.7 Summary of Non-Clinical Testing Bench testing was performed to conf irm that the changes met design requirements…	St Jude Medical	2005	—

Also cleared against K051840: 1 other device →

What descends from it? (29)

See all 29

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K160187	Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0	St Jude Medical	2016	28

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?

Its one ancestor has no recall.
Of its descendants, K160187 (St Jude Medical, 2016) has gone furthest, with 28 descendants of its own.
1 other device also cites its predicate K051840.

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. 2010, this device’s year, is highlighted.

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 EnSite Verismotm Segmentation Tool (EnSite Verismo) (EV1000) is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity1 ~4 System.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101697 · printed Nov 3, 2026

Cite this page

510(k) Report. “K101697: Ensite Verismo Segmentation Tool V.2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101697

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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