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510(k) Data Aggregation
K Number
K120305Device Name
THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV
Manufacturer
THINKING SYSTEMS CORP.
Date Cleared
2012-07-09
(159 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
THINKING SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
OR
- 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.
Device Description
ThinkingNet is a multi-modality PACS/RIS with applications optimized for each individual imaging modality. The image data and applications can be accessed locally or remotely. ThinkingNet workstation software is designed as diagnostic reading and processing software packages, which may be marketed as software only, as well as packaged with standard off-the-shelf computer hardware.
The base functions include receiving, transmission, storage, archival, display images from all imaging modalities. When enabled, the system allows remote access of image data and applications over a local or wide area network, using a Web browser, thick-client, thin-client or cloud-based remote application deployment method.
Options allow for additional capability, including modality specific applications, quantitative postprocessing, modality specific measurements, multi-planar reformatting and 3D visualization.
ThinkingNet Molecular Imaging modules offer the image processing functionality, through MDStation and ThinkingWeb, that have the same indication as the predicate modality workstations. It delivers image processing and review tools for applications used in functional imaging modalities, such as nuclear medicine, PET, PET/CT, SPECT/CT and PET/MRI.
ThinkingNet Mammo module is a diagnostic softcopy breast imaging workstation with diagnostic print capability.
- It displays and prints regionally approved DICOM DR Digital Mammography Images (MG . SOP class) with a default or user defined mammography hanging protocol.
- . It displays and prints regionally approved DICOM CR Digital Mammography Images (CR SOP class) a default or user defined mammography hanging protocol.
- It displays adjunct breast imaging modality studies (i.e. Breast MR, Breast . PET and Breast gamma camera) for comparison.
ThinkingWeb modules offer comprehensive remote image and application access methods to allow clinicians to review and process images remotely. It has the following modules.
- . ThinkingWebLite: Clientless image distribution via simple Web browser (see NuWEB in K010271). It is primarily a referral physician's portal, not intended for primary reading.
- . ThinkingNet.Net: A thick-client implementation using an existing image review module (NuFILM) with a proprietary image streaming mechanism.
- . ThinkingWeb: Cross-platform thin-client remote application access based the existing MDStation software and off-the-shelf remote computing technology.
- . ThinkingWeb Extreme: A cloud-based remote application deployment implementation based the existing MDStation software and off-the-shelf cloud computing technologies.
Besides ThinkingNet.Net, all ThinkingWeb products support cross-platform client computer devices. Thinking Net uses Windows-based client computer.
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K Number
K010271Device Name
THINKINGNET
Manufacturer
THINKING SYSTEMS CORP.
Date Cleared
2001-04-03
(64 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
THINKING SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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