510(k) · Cleared

Cleared

Accusketch Cardiac Quantitative System W/ Advanced Analysis Components

K023100510(k) SpecialCleared Oct 11, 200223-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

General Electric Medical Systems Information Techn · LLZ System, Image Processing, Radiological

Cleared on Oct 11, 2002 as substantially equivalent to K912829 (Cine Graphics, Inc., 1991) and 1 other predicate after a 23-day review. Its family tree reaches back 3 generations to 1984. 23 later devices descend from it.

Decided: Oct 11, 2002
Review: 23 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K842308 (1984). 5 ancestors in all. 23 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
2 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
1 generation backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
This deviceK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
Descendant · cites it directly · 22 of its ownK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
Descendant · cites it directly · 18 of its ownK063628 Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 2006 · Recalled
Descendant · 2 generations on · 8 of its ownK081018 Syngo Dynamics Version 7.0Siemens Medical Solutions · 2008
Descendant · 3 generations on · 7 of its ownK102150 Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc. · 2010 · Recalled
Descendant · 4 generations on · 5 of its ownK123922 Syngo DynamicsSiemens Medical Solutions USA, Inc. · 2013

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2004high 3 (2013) · low 0 (2005)2026

Most influential descendants

Showing 5 of 23 · See all

K042525Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy…Ge Medical Systems Information Technologies · 2004 · cites it directly22descendants
K063628Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 2006 · cites it directly18descendants
K081018Syngo Dynamics Version 7.0Siemens Medical Solutions · 2008 · 2 generations on8descendants
K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc. · 2010 · 3 generations on7descendants
K123922Syngo DynamicsSiemens Medical Solutions USA, Inc. · 2013 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K842308	12SSL-SC	Marquette Electronics, Inc.	1984	—
−2	K980495	Muse Cardiovascular Information System	Marquette Medical Systems, Inc.	1998	—
−1	K992637	Muse Cardiovascular Information System	General Electric Medical Systems Information Techn	1999	1
0 (this device)	K023100	Accusketch Cardiac Quantitative System W/ Advanced Analysis Components	General Electric Medical Systems Information Techn	2002	—
+1	K042525	Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital…	Ge Medical Systems Information Technologies	2004	3
+1	K063628	Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy	Ge Healthcare Integrated IT Solutions	2006	3
+2	K081018	Syngo Dynamics Version 7.0	Siemens Medical Solutions	2008	—
+3	K102150	Syngo Dynamics, Version 9.0	Siemens Medical Solutions USA, Inc.	2010	7
+4	K123922	Syngo Dynamics	Siemens Medical Solutions USA, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	2	0
2008	2	0
2010	1	0
2011	1	0
2012	2	0
2013	3	0
2014	1	0
2015	2	0
2016	1	0
2017	1	0
2018	1	0
2021	1	0
2022	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K023100, 1984–2026Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K912829	Cardiotrace Cardiac Evaluation Systems Summary page 1 …Cardiac Image Analysis Station System, image Processing Radiological Classification Names: Predicate Devices: CardioTrace K912829;*MUSE Cardiovascular Information System with Accusketch K992937 ‘NOT…	Cine Graphics, Inc.	1991	—
*	K992637	Muse Cardiovascular Information System Summary page 1 …anced Analysis Components is being compared to AccuSketch, classification code LLZ, integrated into MUSE in K#992637.MUSE classification codes of DQK Programmable Diagnostic Computer (Class II) and DSI Detector & Ala…	General Electric Medical Systems Information Techn	1999	1

Also cleared against K912829: 1 other device →

What descends from it? (23)

See all 23

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

Number	Device	Applicant	Decided	Descendants
K042525	Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy…	Ge Medical Systems Information Technologies	2004	22
K063628	Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy	Ge Healthcare Integrated IT Solutions	2006	18

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 18 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K042525 (Ge Medical Systems Information Technologies, 2004) has gone furthest, with 22 descendants of its own.
1 other device also cites its predicate K912829.

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?

AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. AccuSketch is intended to provide and document an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023100 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023100: Accusketch Cardiac Quantitative System W/ Advanced Analysis Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023100

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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