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Found 6 results
510(k) Data Aggregation
K Number
K103710Device Name
WBR XPRESS PET
Manufacturer
ULTRASPECT LTD.
Date Cleared
2011-01-19
(30 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
ULTRASPECT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WBR Xpress.PET including the Attenuation & Scattering Corrections is indicated for the acquisition, formatting and storage of scintigraphy output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs
Device Description
The WBR Xpress.PET is image processing system, which is interfaced to PET/CT. Fast acquired, data are reconstructed by the device, which utilizes parallel and non - prrallal beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM compatible. The device includes Attenuation and Scatterng Corrections (ACSC).
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K Number
K091073Device Name
WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS
Manufacturer
ULTRASPECT LTD.
Date Cleared
2009-05-14
(30 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
ULTRASPECT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WBR Xpress3.Cardiac and WBR Xpress.Cardiac including the Attenuation & Scattering Corrections are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs
Device Description
The Xpress.cardiac & Xpress3.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the devices, which utilize parallel and non - parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible. The devices have been modified by including Attenuation and Scattering Corrections (ACSC).
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K Number
K081201Device Name
WBR XPRESS3.CARDIAC
Manufacturer
ULTRASPECT LTD.
Date Cleared
2008-05-28
(30 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
ULTRASPECT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Xpress3.Cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, ind in various forms of animated sequences, showing kinetic attributes of the image organs.
Device Description
The Xpress3.cardiac is an image processing system, which is interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the Xpress3.cardiac. The Xpress3.cardiac utilizes parallel and non - parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
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K Number
K080784Device Name
WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE
Manufacturer
ULTRASPECT LTD.
Date Cleared
2008-04-02
(13 days)
Product Code
KPS, SUB
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
ULTRASPECT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WBR Half Dose is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.
Device Description
The WBR Half dose is a modification of labeling of the legally marketed device. The device is an image processing system, which is interfaced to gamma cameras, processes the cameras' acquired data utilizing parallel and non - parallel beams and produce high resolution images. The images can be transfered to any other PACS device, which is DICOM or Interfile compatible. The modified labeling claims that, as far as the acquired information density is maintained. the same image quality is achieved either by fast acquisition or by reduced dose acquisition modes.
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K Number
K050815Device Name
XACT.CARDIAC & XPRESS.CARDIAC
Manufacturer
ULTRASPECT LTD.
Date Cleared
2005-04-26
(26 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
ULTRASPECT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WBR Xact.cardiac & Xpress.cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.
Device Description
The Xact.cardiac & Xpress.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac data is reconstructed by the Xact.cardiac. . Gamma camera cardiac, fast acquired, data is reconstructed by the Xpress.cardiac. The Xact.cardiac & Xpress.cardiac utilize parallel and non parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
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K Number
K040370Device Name
WBR-FHR, WBR-FWB
Manufacturer
ULTRASPECT LTD.
Date Cleared
2004-03-11
(27 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
ULTRASPECT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WBR - thr, wBR - wb are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.
Device Description
The WBR -- fHR and the WBR -- fWB are image processing systems, which are interfaced to gamma cameras. Camera- fast acquired data is reconstructed by the WBR - FHR or processed by the WBR - fWB, which utilize parallel and non parallel beams and produce high resolution images. The images can be transferred to any other PAC'S device, which is DICOM or Interfile compatible.
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