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Found 4 results
510(k) Data Aggregation
K Number
K071584Device Name
OASIS RELEASE 1.0
Manufacturer
SEGAMI CORPORATION
Date Cleared
2007-08-31
(81 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SEGAMI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oasis system is indicated for the processing and review of scintigraphy data and other related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of processing and displaying the medical image data 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. The Oasis system displays the processed images using an integrated computer. Oasis provides manual and automatic report creation plus the ability to view these reports remotely. Oasis also provides patient scheduling tools. This device is not used in the primary diagnosis of Mammography images.
Device Description
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K Number
K070397Device Name
DGSCOPE, RELEASE 1.0
Manufacturer
SEGAMI CORPORATION
Date Cleared
2007-04-13
(60 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SEGAMI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DGSCOPE system is indicated for the review of diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. The DGSCOPE system displays the processed images using an integrated computer. The DGSCOPE's PC's surfaces can be disinfected using an FDA approved liquid disinfectant indicating that the use of the DGSCOPE system is appropriate in an operating room environment. The display of CT, MR, X-Ray, NM, US, and other diagnostic data is in the standard planar and pseudo-three dimensional formats in both static and dynamic review modes. This device is not used in the primary diagnosis of Mammography images.
Device Description
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K Number
K070683Device Name
MIRAGE CEDARS OPTION
Manufacturer
SEGAMI CORPORATION
Date Cleared
2007-04-12
(31 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SEGAMI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mirage system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. 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
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K Number
K043441Device Name
MIRAGE, RELEASE 5.5
Manufacturer
SEGAMI CORPORATION
Date Cleared
2005-01-13
(30 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
SEGAMI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mirage Release 5.5 system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. 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
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