510(k) Report

510(k) · Cleared

Recalled · 2008

Centricity AW Suite Option

K061372510(k) TraditionalCleared May 30, 200613-day reviewClass II21 CFR 892.2050Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ge Healthcare Information Technologies · LLZ System, Image Processing, Radiological

Cleared on May 30, 2006 as substantially equivalent to K043415 (Ge Medical Systems Information Technologies, 2005) and 6 other predicates after a 13-day review. Its family tree reaches back 6 generations to 1991. It has been recalled 2 times.

Decided
May 30, 2006
Review
13 days
Class
Class II
Product code
LLZ
Recalls
2
Predicates
7

Its longest line of descent runs back 6 generations to K913770 (1991). 35 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2004: 3 other ancestors2003: 3 other ancestors1999: 1 other ancestor2002: 4 other ancestors2001: 3 other ancestors2000: 4 other ancestors1997: 2 other ancestors1995: 1 other ancestor1993: 2 other ancestors1998: 1 other ancestor1992: 1 other ancestor1987: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestorK913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991K963345 · Advantage Windows Tissue Volume Option · GE Medical Systems · 1996K013381 · Advanced Lung Analysis-1 · General Electric Co. · 2001K022013 · Lungcare CT Software Package · Siemens Medical Solutions USA, Inc. · 2002K033374 · Lungcare CT Software Package with Extended Functionality · Siemens AG Medical Solutions · 2003K042694 · Advanced Lung Analysis II · GE Medical Systems · 200419851990199520002005
  1. Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 5 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
  3. 4 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
  4. 3 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
  5. 2 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
  6. 1 generation backK042694 Advanced Lung Analysis IIGE Medical Systems · 2004
  7. This deviceK061372 Centricity AW Suite OptionGe Healthcare Information Technologies · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K913770Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co.1991—
−5K963345Advantage Windows Tissue Volume OptionGE Medical Systems1996—
−4K013381Advanced Lung Analysis-1General Electric Co.2001—
−3K022013Lungcare CT Software PackageSiemens Medical Solutions USA, Inc.2002—
−2K033374Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions2003—
−1K042694Advanced Lung Analysis IIGE Medical Systems2004—
0 (this device)K061372Centricity AW Suite OptionGe Healthcare Information Technologies2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199210
199320
199410
199510
199610
199720
199810
199910
200040
200130
200240
200330
200430
200510
FIG. 1 — Lineage of K061372, 1991–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K043415Centricity Pacs System
Summary page 1
…anced applications are classified as: 21 CFR 892.1750 Computed Tomography X-ray System (accessory to) Predicate Device, K043415:Centricity PACS System K993792: Smart Vessel Analysis Option K0…
Ge Medical Systems Information Technologies200523
*K993792Smart Vessel Analysis (Smart VA) Option
Summary page 1
…21 CFR 892.1750 Computed Tomography X-ray System (accessory to) Predicate Device, K043415:Centricity PACS System K993792: Smart Vessel Analysis Option K042694: Advanced Lung Analysis IIOption…
Ge Medical Systems, Inc.1999—
*K042694Advanced Lung Analysis II
Summary page 1
…) Predicate Device, K043415:Centricity PACS System K993792: Smart Vessel Analysis Option K042694: Advanced Lung Analysis IIOption K031871: AutoBone Option K0412…
GE Medical Systems2004—
*K031871Autobone
Summary page 1
…K993792: Smart Vessel Analysis Option K042694: Advanced Lung Analysis IIOption K031871: AutoBone Option K041267: Card IQAnalysis III Option K041270: C…
Ge Medical Systems Europe2003—
*K041267Cardiq Analysis Iii
Summary page 1
…tion K042694: Advanced Lung Analysis IIOption K031871: AutoBone Option K041267: Card IQAnalysis III Option K041270: CT Colonography IIOption K…
General Electric Medical Systems2004—
*K041270CT Colonography II
Summary page 1
…IIOption K031871: AutoBone Option K041267: Card IQAnalysis III Option K041270: CT Colonography IIOption K041521: Volume Viewer Plus Option Device Description: Cent…
General Electric Medical Systems2004—
*K041521Volume Viewer Plus
Summary page 1
…K041267: Card IQAnalysis III Option K041270: CT Colonography IIOption K041521: Volume Viewer Plus Option Device Description: Centricity AW Suite is a software option that provides an interface bet…
General Electric Medical Systems20042

Also cleared against K043415: 10 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)

Recalls of this device

DateClassRecallRoot causeReason
Jun 11, 2008Not classifiedZ-2183-2008Software designWhen using any vessel analysis protocol of the AW Suite Card IQ application, the software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the restored images. This failure only occurs…
May 9, 2008Not classifiedZ-1825-2008Software designIncorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or customized protocol of the Centricity AW Suite 2.0 running on the Centricity RA 1000 or RA600/CA1000 workstations.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
  • 7 of the 35 ancestors have a recall of any class.
  • 10 other devices also cite its predicate K043415.

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

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
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

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

Centricity AW Suite is an optional software package that provides an interface between the Centricity PACS Workstation and Volume Viewer such that both applications con run on a single platform while maintaining common patient & exam context. Optional advanced analysis extensions of the Volume Viewer application include: AutoBone, Advanced Vessel Analysis, CT Colonography, CardlQ Analysis, and Advanced Lung Analysis. Volume Viewer allows the processing…

Read the full statement (540 words)

Centricity AW Suite is an optional software package that provides an interface between the Centricity PACS Workstation and Volume Viewer such that both applications con run on a single platform while maintaining common patient & exam context. Optional advanced analysis extensions of the Volume Viewer application include: AutoBone, Advanced Vessel Analysis, CT Colonography, CardlQ Analysis, and Advanced Lung Analysis.

Volume Viewer allows the processing, review, analysis and communication of 3D reconstructed images and their relationship to originally acquired images from CT, MR, X-Ray Angio, NM and PET Scanning devices. The combination of acquired images. reconstructed images. annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning.

Advanced Vessel Analysis can be used in the analysis of 3D angiography data. Itprovides a number of display, measurement and batch archive features and will aid physicians in studying user-selected vessels for stenosis analysis. pre/post stent planning and directional vessel tortuosity visualization.

CardlQ Analysis allows the visualization of 2D and 30 medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionality for 2D/30 rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process. render, review, archive and visualize cardiac anatomy and coronary vessels.

CT Colonography allows the visualization of 20 and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses. cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 20. 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists. Clinicians, and referring Physicians to process, render, review, archive and distribute colon image studies.

AutoBone is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data.

Advanced Lung Analysis is intended to provide on optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images. The software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol. thus providing an estimation of the volume doubling time. ALA software allows analysis and displays statistics for nodule characterization all the different nodule types. ALA optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (S)and cylindrical (C)anatomical regions. such as nodules, cysts. scars, and vessels Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process. ALA provides additional information to the physician and is intended to compliment diagnosis based on classical techniques.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K061372: Centricity AW Suite Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061372

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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