510(k) · Cleared

Cleared

Ziostation2

K151212510(k) TraditionalCleared Nov 4, 2015182-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

Qi Imaging, LLC · LLZ System, Image Processing, Radiological

Cleared on Nov 4, 2015 as substantially equivalent to K070205 (Ziosoft, Inc., 2007) and 14 other predicates after a 182-day review. Its family tree reaches back 11 generations to 1997. 9 of the 142 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.

Decided: Nov 4, 2015
Review: 182 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 15

Its longest line of descent runs back 11 generations to K971684 (1997). 139 ancestors in all, the oldest K871859 (1987). 2 later devices descend from it, 1 citing it directly. 9 of the 142 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 11 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
7 generations between
3 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
2 generations backK103327 Discovery MR750W 3.0TGe Healthcare Japan Corporation · 2011 · Recalled
1 generation backK121676 1.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC · 2012 · Recalled
This deviceK151212 Ziostation2Qi Imaging, LLC · 2015
Descendant · cites it directly · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
Descendant · 2 generations on · 0 of its ownK200315 Ziostation2Ziosoft, Inc. · 2020

Show all 11 generations

Root · 11 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
10 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
9 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
8 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
7 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
6 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
5 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
4 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
3 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
2 generations backK103327 Discovery MR750W 3.0TGe Healthcare Japan Corporation · 2011 · Recalled
1 generation backK121676 1.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC · 2012 · Recalled
This deviceK151212 Ziostation2Qi Imaging, LLC · 2015

Class I recalls in this family

K063559 Achieva, Intera and Panorama 1.0T, Release 2.52 generations back · 2007
K043147 Achieva Family2 generations back · 2005
K052078 Achieva, Intera and Panorama 1.0 Release 2-Series3 generations back · 2005
K041602 Panorama 1.0T3 generations back · 2004

Most influential descendants

Showing 2 of 2 · See all

K181892Ziostation2Ziosoft, Inc. · 2018 · cites it directly1descendant
K200315Ziostation2Ziosoft, Inc. · 2020 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−11	K971684	Magnetom Project 047 System (Numaris 3.5 Software)	Siemens Medical Solutions USA, Inc.	1997	4
−10	K032428	Magnetom Avanto MR System	Siemens Medical Solutions USA, Inc.	2003	4
−9	K041112	Magnetom Espree System	Siemens Medical Solutions USA, Inc.	2004	4
−8	K052164	Magnetom Systems with Software Syngo MR 2006A	Siemens Medical Solutions USA, Inc.	2005	—
−7	K062454	Magnetom Systems - I-Class and T-Class Releases	Siemens Medi Cal Solutions, Inc.	2006	—
−6	K072237	Magnetom Verio	Siemens Medical Solutions USA, Inc.	2007	Class I
−5	K081028	Signa 3.0T MR750 System	Ge Medical Systems, LLC	2008	11
−4	K083147	Discovery MR450	Ge Medical Systems, LLC	2008	10
−3	K091536	Optima MR450W	Ge Medical Systems, LLC	2009	8
−2	K103327	Discovery MR750W 3.0T	Ge Healthcare Japan Corporation	2011	6
−1	K121676	1.5T Signa HDXT 3.0T Signa HDXT Signa Vibrant	Ge Medical Systems, LLC	2012	10
0 (this device)	K151212	Ziostation2	Qi Imaging, LLC	2015	—
+1	K181892	Ziostation2	Ziosoft, Inc.	2018	—
+2	K200315	Ziostation2	Ziosoft, Inc.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1988	2	0
1989	1	0
1991	2	0
1993	1	0
1994	2	0
1995	3	0
1996	6	0
1997	4	0
1998	5	0
1999	5	0
2000	6	0
2001	11	1
2002	10	1
2003	9	1
2004	11	2
2005	13	2
2006	7	0
2007	7	1
2008	7	0
2009	4	0
2011	6	0
2012	3	0
2013	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2020	1	0

FIG. 1 — Lineage of K151212, 1997–2020Source: 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.

9 devices in this family have 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? (15)

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
*	K070205	Ziostation Summary page 5 …Number Ziostation K070205 (Multiple Protocol Enhancements) Ziostation with…	Ziosoft, Inc.	2007	—
*	K083446	Cardiac Function Analysis, Calcium Scoring Summary page 5 …(Multiple Protocol Enhancements) Ziostation with K083446 Cardiac Function Analysis and Calcium Scoring Software CARDIQ Express v2.0…	Ziosoft, Inc.	2009	—
*	K073138	Cardiq Express Version 2.0 Summary page 5 …K083446 Cardiac Function Analysis and Calcium Scoring Software CARDIQ Express v2.0 K073138 EBW NM 2.0 K111336 PET VCAR…	GE Medical Systems	2008	—
*	K111336	EBW NM 2.0 Summary page 5 …coring Software CARDIQ Express v2.0 K073138 EBW NM 2.0 K111336 PET VCAR K063324 CT Perfusi…	Philips Medical Systems (Cleveland), Inc.	2011	—
*	K063324	Pet Vcar Summary page 5 …K073138 EBW NM 2.0 K111336 PET VCAR K063324 CT Perfusion 4 K052839 Vitrea CT Myocardia…	GE Healthcare	2007	1
*	K052839	CT Perfusion 4 Summary page 5 …K111336 PET VCAR K063324 CT Perfusion 4 K052839 Vitrea CT Myocardial Analysis K112531 Syngo Volume Perfusion…	GE Healthcare	2006	1
*	K112531	Vitrea CT Myocardial Analysis Summary page 5 …K063324 CT Perfusion 4 K052839 Vitrea CT Myocardial Analysis K112531 Syngo Volume Perfusion, CT Body K092013 AW Volume Sha…	Vital Images, Inc.	2011	—
*	K092013	Syngo Volume Perfusion-CT Body Summary page 5 …K052839 Vitrea CT Myocardial Analysis K112531 Syngo Volume Perfusion, CT Body K092013 AW Volume Share 5 K110834 Synapse 3D Liver…	Siemens AG Medical Solutions	2009	—
*	K110834	AW Volumeshare 5 with Angioviz Option Summary page 5 …K112531 Syngo Volume Perfusion, CT Body K092013 AW Volume Share 5 K110834 Synapse 3D Liver Analysis K110186 Signa HDxT…	GE Healthcare	2011	1
*	K110186	Synapse 3D Liver Analysis Summary page 5 …K092013 AW Volume Share 5 K110834 Synapse 3D Liver Analysis K110186 Signa HDxT HD K121676 Achieva R2 1.5…	Fujifilm Medical System U.S.A., Inc.	2011	—
*	K121676	1.5T Signa HDXT 3.0T Signa HDXT Signa Vibrant Summary page 5 …K110834 Synapse 3D Liver Analysis K110186 Signa HDxT HD K121676 Achieva R2 1.5T/3.0T K110151 Sure…	Ge Medical Systems, LLC	2012	10
*	K110151	Achieva R4 1.5T and Achieva R4 3.0T Summary page 5 …K110186 Signa HDxT HD K121676 Achieva R2 1.5T/3.0T K110151 Sure Subtraction Ortho CSSO-001A K130960…	Philips Health Care	2011	20
*	K130960	Suresubtraction Ortho Summary page 5 …Achieva R2 1.5T/3.0T K110151 Sure Subtraction Ortho CSSO-001A K130960 CardEP K031261 Vitrea CT Transcatheter Aortic Valv…	Toshibamedical Systems Corporation	2013	—
*	K031261	Card EP Summary page 5 …Sure Subtraction Ortho CSSO-001A K130960 CardEP K031261 Vitrea CT Transcatheter Aortic Valve Replacement Planning K122578 Device Description ZIOSTATION2 is a basic DI…	GE Medical Systems	2003	—
*	K122578	Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) Planning Summary page 5 …K130960 CardEP K031261 Vitrea CT Transcatheter Aortic Valve Replacement Planning K122578 Device Description ZIOSTATION2 is a basic DICOM image management system to further aid clinicians in their analysis of anatom…	Vital Images, Inc.	2013	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K181892	Ziostation2	Ziosoft, Inc.	2018	1

Has anything in its family been recalled? (9 Class I)

No FDA recall names this device.

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.

K063559Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 5 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall

Nearest 5 of 9; all are on the web page.

What does this lineage say?

The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 12 months on median.
53 of the 139 ancestors have a recall of any class; 9 have a Class I recall.
Of its descendants, K181892 (Ziosoft, Inc., 2018) has gone furthest, with 1 descendant of its own.

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. 2015, 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?

Ziostation2 is an image processing application software available for installation onto customer owned hardware. This application software can be networked to provide for sharing of resources. This application software receives medical images from modalities (medical image scanning devices such as CT) or image archives such as PACS through network or media and provides for the viewing, quantification, manipulation, communication. printing, and management…

Read the full statement (128 words)

Ziostation2 is an image processing application software available for installation onto customer owned hardware. This application software can be networked to provide for sharing of resources.

This application software receives medical images from modalities (medical image scanning devices such as CT) or image archives such as PACS through network or media and provides for the viewing, quantification, manipulation, communication. printing, and management of medical images.

This application software is intended for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor whose characteristics are approved by the regulatory agency governing the market within which Ziostation2 is being offered.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K151212 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151212: Ziostation2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151212

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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