510(k) · Cleared

Recalled · Class II · 2012

Seno Advantage

K033400510(k) TraditionalCleared Dec 4, 200341-day reviewClass II21 CFR 892.2050Recalls 6

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

Ge Medical Systems W-400 · LLZ System, Image Processing, Radiological

Cleared on Dec 4, 2003 as substantially equivalent to K020483 (GE Medical Systems, 2002) after a 41-day review. Its family tree reaches back 3 generations to 1991. 1 of the 642 devices in its family, counting itself, has a Class I recall. 637 later devices descend from it. It has been recalled 6 times.

Decided: Dec 4, 2003
Review: 41 days
Class: Class II
Product code: LLZ
Recalls: 6
Predicates: 1

Its longest line of descent runs back 3 generations to K913770 (1991). 4 ancestors in all. 637 later devices descend from it, 9 citing it directly. 1 of the 642 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
2 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
1 generation backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
This deviceK033400 Seno AdvantageGe Medical Systems W-400 · 2003
Descendant · cites it directly · 324 of its ownK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
Descendant · 2 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
Descendant · cites it directly · 263 of its ownK043216 Cadstream Version 4.0Confirma, Inc. · 2005
Descendant · 3 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
Descendant · 2 generations on · 123 of its ownK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005

Showing 5 of 637 descendants. See all descendants

Descendants cleared per year

2004high 61 (2025) · low 3 (2004)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025

Most influential descendants

Showing 5 of 637 · See all

K043415Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · cites it directly324descendants
K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 2 generations on287descendants
K043216Cadstream Version 4.0Confirma, Inc. · 2005 · cites it directly263descendants
K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on200descendants
K050846B-Cad System, Version 1.0The Medipattern Corporation · 2005 · 2 generations on123descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K913770	Advantage V.S. CT/MR Rad Diagnostic Workstation	General Electric Co.	1991	—
−2	K960613	GE Advantage Windows Review Workstation	GE Medical Systems	1996	—
−1	K020483	Advantage Workstation 4.1	GE Medical Systems	2002	2
0 (this device)	K033400	Seno Advantage	Ge Medical Systems W-400	2003	—
+1	K043415	Centricity Pacs System	Ge Medical Systems Information Technologies	2005	23
+2	K071964	Mim 4.1 (Seastar)	Mimvista Corp.	2007	2
+1	K043216	Cadstream Version 4.0	Confirma, Inc.	2005	—
+3	K091373	Syngo Trued	Siemens Medical Solutions USA, Inc.	2009	—
+2	K050846	B-Cad System, Version 1.0	The Medipattern Corporation	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	0
2005	8	0
2006	5	0
2007	6	0
2008	9	0
2009	12	0
2010	7	0
2011	12	0
2012	14	0
2013	12	0
2014	23	0
2015	23	0
2016	29	0
2017	33	0
2018	49	0
2019	41	0
2020	42	0
2021	52	0
2022	50	0
2023	44	0
2024	51	0
2025	61	1
2026	51	0

FIG. 1 — Lineage of K033400, 1991–2026Source: 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.

1 device in this family has a Class I recall. 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? (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
*	K020483	Advantage Workstation 4.1 Summary page 1 …listed below: Model: Advantage Windows Review Workstation Manufacturer: General Electric Medical Systems 510 (k): K020483 4. Device Description: The Seno Advantage Workstation is a multi-modality review workstation. It includes a color flat…	GE Medical Systems	2002	2

Also cleared against K020483: 4 other devices →

What descends from it? (637)

See all 637

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

Number	Device	Applicant	Decided	Descendants
K043415	Centricity Pacs System	Ge Medical Systems Information Technologies	2005	324
K043216	Cadstream Version 4.0	Confirma, Inc.	2005	263
K073272	Workstationone Breast Imaging Workstation	Three Palm Software, LLC	2007	27
K041555	Securview DX Softcopy Workstation	Hologic, Inc.	2004	16
K040555	Impax Client Embrace	Agfa Corp.	2004	6
K080351	Dexela Dex Top Mammography Workstation, Model Mamwkvi	Dexela, Ltd.	2008	2
K041935	DR Systems Pacs, Release 6.1	Dr Systems, Inc.	2004	1
K083740	Mammodiagnost VU	Philips Medical Systems Nederland B.V.	2009	0
K052537	Catella Diagnostic Workstation, Version 4.0	American Medical Sales, Inc.	2005	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 20, 2012	Class II	Z-2257-2013	Software design	GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety.
May 24, 2012	Class II	Z-0095-2013	Software design	GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the…
May 24, 2012	Class II	Z-0125-2013	Software design	GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.
May 31, 2011	Not classified	Z-3012-2011	Software design	GE Healthcare has become aware that patient mismatch could occur on some Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration. This issue may impact patient safety. When Seno Advantage workstation is synchronized with RIS…
Feb 9, 2010	Not classified	Z-1747-2010	Software design	GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. When using the Print Image or Print Screen feature on SenoAdvantage 2.2, the Scale…
Aug 28, 2009	Not classified	Z-0476-2011	Software design	The measurement values provided by the GE Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiver, this could lead to an overestimate of the size of…

The 5 latest of 6 recalls; the web page lists all.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
1 of the 4 ancestors has a recall of any class.
Of its descendants, K043415 (Ge Medical Systems Information Technologies, 2005) has gone furthest, with 324 descendants of its own.
4 other devices also cite its predicate K020483.

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?

Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033400 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033400: Seno Advantage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033400

Report an extraction error

Are you the manufacturer?

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