510(k) · Cleared

Cleared

GE Logiq Works

K063006510(k) SpecialCleared Nov 2, 200631-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 Co. · LLZ System, Image Processing, Radiological

Cleared on Nov 2, 2006 as substantially equivalent to K963699 (Belmont Equipment Corp., 1996) and 3 other predicates after a 31-day review. Its family tree reaches back 5 generations to 1984.

Decided: Nov 2, 2006
Review: 31 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 4

Its longest line of descent runs back 5 generations to K842308 (1984). 15 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
4 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
3 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
2 generations backK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
1 generation backK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
This deviceK063006 GE Logiq WorksGeneral Electric Co. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K842308	12SSL-SC	Marquette Electronics, Inc.	1984	—
−4	K980495	Muse Cardiovascular Information System	Marquette Medical Systems, Inc.	1998	—
−3	K992637	Muse Cardiovascular Information System	General Electric Medical Systems Information Techn	1999	1
−2	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
0 (this device)	K063006	GE Logiq Works	General Electric Co.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0
1990	1	0
1991	2	0
1992	1	0
1996	2	0
1998	2	0
2002	1	0

FIG. 1 — Lineage of K063006, 1984–2006Source: 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

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What was it cleared against? (4)

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
*	K963699	Belray/Model 096, Dental Intraoral X-Ray Summary page 1 …GIQworks TM Ultrasound Image Workstation System, Image Processing, Radiological, 21 CFR 892.2050, 90-LLZ 3. Marketed Device: RadWorks Review K963699, Platinum PACS Workstation K981217, Centricity PACS Plus K023557 and Centricity RA 600 K042525; all a…	Belmont Equipment Corp.	1996	—
*	K981217	Platinum Reading, Review & Analysis Workstation Summary page 1 …ation System, Image Processing, Radiological, 21 CFR 892.2050, 90-LLZ 3. Marketed Device: RadWorks Review K963699, Platinum PACS Workstation K981217, Centricity PACS Plus K023557 and Centricity RA 600 K042525; all are 90-LLZ 4. Device Description: Th…	GE Medical Systems	1998	—
*	K023557	Centricity Pacs Plus Summary page 1 …diological, 21 CFR 892.2050, 90-LLZ 3. Marketed Device: RadWorks Review K963699, Platinum PACS Workstation K981217, Centricity PACS Plus K023557 and Centricity RA 600 K042525; all are 90-LLZ 4. Device Description: The GE LOGIO Works Image Analysis and Review Workstation is…	GE Medical Systems	2002	—
*	K042525	Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy… Summary page 1 …0-LLZ 3. Marketed Device: RadWorks Review K963699, Platinum PACS Workstation K981217, Centricity PACS Plus K023557 and Centricity RA 600 K042525; all are 90-LLZ 4. Device Description: The GE LOGIO Works Image Analysis and Review Workstation is optimized for ultrasound image…	Ge Medical Systems Information Technologies	2004	3

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 22 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
2 of the 15 ancestors have a recall of any class.

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?

To retrieve and display for reading, diagnostic review, analysis and measurement of digital medical images acquired from DICOM compliant acquisition systems such as CT, MR, PET, X-ray and Ultrasound.

Also, for images acquired from GE LOGIQ ultrasound, to process, analyze and manipulate images with the same post acquisition capability as that provided on the GE LOGIQ ultrasound scanner.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063006 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063006: GE Logiq Works.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063006

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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