# K120305: Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or Nupax) - the Management and Archiv

- Pathway: 510(k) (Traditional)
- Applicant: Thinking Systems Corp.
- Decided: Jul 9, 2012 after 159 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003931 (2001). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063267: Isite Pacs, V 4. X, Stentor Inc., A Philips Medical Systems Co. (2006) Summary page 3.
- K013630: Isite Radiology, Stentor, Inc. (2001) Summary page 4.
- K010271: Thinkingnet, Thinking Systems Corp. (2001) Summary page 2.
- K093982: Xeleris 3 Processing and Review Workstation, Ge Medical Systems F.I. Haifa (2010) Summary page 4.
- K050228: Agfa Heartlab Cardiovascular, Heartlab, Inc. (2005) Summary page 4.
- K081976: Impax MA3000 Diagnostic Pacs Workstation, Agfa Healthcare Corporation (2008) Summary page 4.
- K101324: GE Echopac Model BT10, Ge Vingmed Ultrasound AS (2010) Summary page 4.
- K081985: AW Server, Ge Medical Systems, LLC (2008) Summary page 4.

## Indications for use
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, cardiologists, physicians, technologists and clinicians. - 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.

Source page: https://510kreport.com/device/K120305
Methodology: https://510kreport.com/methodology