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510(k) Data Aggregation
K Number
K042292Device Name
ISITE PACS
Manufacturer
STENTOR, INC.
Date Cleared
2004-09-08
(15 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
STENTOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging device or modalities.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Description
iSite is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
The system is a software package that is used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage.
iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems.
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K Number
K013630Device Name
ISITE RADIOLOGY
Manufacturer
STENTOR, INC.
Date Cleared
2001-12-05
(30 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
STENTOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stentors' iSite Radiology is a medical image softcopy reading software package to be used for display of digital radiology images.
Device Description
iSite Radiology is designed as a Diagnostic reading workstation. iSite Radiology is capable of receiving and displaying DICOM images. Images sent to ISite Radiology are converted into formats suitable for viewing in its framework, and stored in a local cache. ISite Radiology is used by ISite Radiology to view JPEG and wavelet images follow known and accepted protocols. Images sent to ISite Radiology can be viewed using an executable that is installed on a Personal Computer equipped with the appropriate hardware. ISite Radiology uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack.
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K Number
K992698Device Name
STENTOR, PAGEVIEW
Manufacturer
STENTOR, INC.
Date Cleared
1999-10-25
(75 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
STENTOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images.
Device Description
Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images.
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