510(k) · Cleared

Cleared

Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or Nupax) - the Management and Archiv

K120305510(k) TraditionalCleared Jul 9, 2012159-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

Thinking Systems Corp. · LLZ System, Image Processing, Radiological

Cleared on Jul 9, 2012 as substantially equivalent to K063267 (Stentor Inc., A Philips Medical Systems Co., 2006) and 7 other predicates after a 159-day review. Its family tree reaches back 7 generations to 2001.

Decided: Jul 9, 2012
Review: 159 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 8

Its longest line of descent runs back 7 generations to K003931 (2001). 62 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 7 generations backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
6 generations backK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
5 generations backK041552 GE Vivid 7 BT04General Electric Co. · 2004
4 generations backK051449 GE Vivid 7 with or Without SuffixGE Medical Systems · 2005
3 generations backK060542 GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co. · 2006 · Recalled
2 generations backK072952 GE EchopacGeneral Electric Co. · 2007
1 generation backK101324 GE Echopac Model BT10Ge Vingmed Ultrasound AS · 2010
This deviceK120305 Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet…Thinking Systems Corp. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K003931	Vivid 7 with Sonopac, Model FB0008XX	Ge Medical Systems, Inc.	2001	—
−6	K031663	GE Vivid 7, Model FC0003XX	General Electric Co.	2003	—
−5	K041552	GE Vivid 7 BT04	General Electric Co.	2004	—
−4	K051449	GE Vivid 7 with or Without Suffix	GE Medical Systems	2005	—
−3	K060542	GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX	General Electric Co.	2006	1
−2	K072952	GE Echopac	General Electric Co.	2007	—
−1	K101324	GE Echopac Model BT10	Ge Vingmed Ultrasound AS	2010	—
0 (this device)	K120305	Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet…	Thinking Systems Corp.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1991	2	0
1992	1	0
1993	3	0
1994	2	0
1995	2	0
1996	6	0
1997	4	0
1998	3	0
2000	4	0
2001	4	0
2002	4	0
2003	3	0
2004	3	0
2005	5	0
2006	2	0
2007	1	0
2008	3	0
2009	1	0
2010	1	0

FIG. 1 — Lineage of K120305, 2001–2012Source: 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? (8)

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
*	K063267	Isite Pacs, V 4. X Summary page 3 …FDA Clearance Primary Indications Number Philips/Stentor iSite PACS 4.x and iSite K063267,K1(13630 Web-based Multi-modality Radiology (primary predicate) PAGS and PACS…	Stentor Inc., A Philips Medical Systems Co.	2006	4
*	K013630	Isite Radiology Summary page 4 …r use, target populations and technical characteristics as the legally marketed predicate device Philips iSite PACS with iSite Radiology client (K063267, K01 3630) and ThinkingNet (KOl 0271). They are substantially equivalent. The main difference between ThinkingNet and Phili…	Stentor, Inc.	2001	—
*	K010271	Thinkingnet Summary page 2 …o review and process images remotely. It has the following modules. * ThinkingWebLite: Clientless image distribution via simple Web browser (see NuWEB in K<010271). It is primarily a referral physician's portal, not intended for primary reading. * ThinkingNet. Net: A thick-client impleme…	Thinking Systems Corp.	2001	—
*	K093982	Xeleris 3 Processing and Review Workstation Summary page 4 …er x ThinkingNet Premarket Notification [51 0(k)] K093982 Nuclear medicine, multi- modality image co-…	Ge Medical Systems F.I. Haifa	2010	1
*	K050228	Agfa Heartlab Cardiovascular Summary page 4 …MSPECT, Syntermed ECTb and Syntermed Neuroal Agfa/F-eartlab Ascentia K050228 Cardiology PACS Agfa IMPAX MA3000 K081 976 Mammography review GE EchoPAC…	Heartlab, Inc.	2005	22
*	K081976	Impax MA3000 Diagnostic Pacs Workstation Summary page 4 …and Syntermed Neuroal Agfa/F-eartlab Ascentia K050228 Cardiology PACS Agfa IMPAX MA3000 K081 976 Mammography review GE EchoPAC K101 324 Echocardiography and…	Agfa Healthcare Corporation	2008	1
*	K101324	GE Echopac Model BT10 Summary page 4 …8 Cardiology PACS Agfa IMPAX MA3000 K081 976 Mammography review GE EchoPAC K101 324 Echocardiography and vascular image review,…	Ge Vingmed Ultrasound AS	2010	—
*	K081985	AW Server Summary page 4 …measurements and calculation GE AW Server KO081985 RECIST, Quantitative oncology response…	Ge Medical Systems, LLC	2008	5

Also cleared against K063267: 2 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)

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 11 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
22 of the 62 ancestors have a recall of any class.
2 other devices also cite its predicate K063267.

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. 2012, 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?

The ThinkingNet is a Medical Image Management and Review System, commonly known as PACS. ThinkingNet made by Thinking Systems Corporation, Florida, USA, is indicated for acceptance, transmission, storage, archival, reading, interpretation, clinical review, analysis, annotation, distribution, printing, editing and processing of digital images and data acquired from DICOM compatible diagnostic device, by healthcare professionals, including radiologists…

Read the full statement (269 words)

- With a ThinkingWeb option it can be used to access diagnostic information remotely with all workstation functionality or to collaborate with other users. The client device is cross platform for all but the thick-client ThinkingNet.Net option.

- With the molecular imaging option it can be used for processing and interpreting nuclear medicine and other molecular imaging studies.

- With image co-registration and fusion option it can be used for processing and interpreting PET-CT, PET-MRI, SPECT-CT and other hybrid imaging studies.

- With the Mammography option it can be used for screening and diagnosis (with MG, "For presentation" images only) from FDA approved modalities in softcopy (using FDA cleared displays for mammography) and printed formats.

- With the cardiology option it can be used for reading, interpreting and reporting cardiac studies, such as nuclear cardiac, PET cardiac, echocardiographic, X-ray angiographic and CTA studies.

- With the Orthopedic option it can be used to perform common orthopedic measurements of the hip, knee, spine, etc.

- With the 3D/MPR option it can be used to volumetric image data visualization: MIP, MPR, VR and triangulation.

- With the Quality Assurance option it can be used by PACS administrators or clinicians to perform quality control activities related to patient and images data.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120305 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120305: Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or Nupax) - the Management and Archiv.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120305

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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