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510(k) Data Aggregation
K Number
K120380Device Name
SATURN 8000
Manufacturer
NEW MEDICAL CO., LTD.
Date Cleared
2012-03-09
(31 days)
Product Code
MQB, REG
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
NEW MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digital X-ray Capture Device Saturn 8000 Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
Device Description
The "Digital X-ray Capture Device (Saturn 8000 System)" (as Saturn 8000 System) is equipped with digital detector. X-ray generator interface, and image acquisition. The digital detector is a flat panel detector. The input X-ray photons are absorbed in scintillator layer that creates a visible light photon, and then the photon is absorbed in TFT-array to create an electrical charge which is representation of the X-ray inout. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. Interfacing with generator can be achieved by Automatic Exposure Detection ("AED") technology which allows detector to automatically detects X-ray exposure. The Saturn 8000 System contains the operation workstation software, which is installed on acquisition workstation ("AWS"), which contains monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.
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K Number
K110210Device Name
SATURN 8000-GS
Manufacturer
NEW MEDICAL CO., LTD.
Date Cleared
2011-04-20
(85 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
NEW MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digital X-ray Capture Device Saturn 8000-GS Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammography applications).
Device Description
The "Digital X-ray Capture Device (Saturn 8000-GS System)" (as Saturn 8000-GS System) is equipped with digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a flat panel detector. The input X-ray photons are absorbed in scintillator layer that creates a visible light photon, and then the photon is absorbed in TFT-array to create an electrical charge which is representation of the X-ray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure can be triggered by detector, which initiate the exposure signal to the generator; or the exposure signal is triggered by the generator itself and the detector is acted as bucky receptor. The connection between generator and detector is via the hardware interface box (HB), which can also connect the hand switch. The Saturn 8000-GS System contains the operation workstation software, which is installed on acquisition ("AWS"), which contains monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.
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K Number
K080589Device Name
SATURN 9000-810
Manufacturer
NEW MEDICAL CO., LTD.
Date Cleared
2008-06-11
(100 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
NEW MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Saturn 9000-810 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-810 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-810 is intended to be used in same clinical application as traditional film-screen based general radiography system.
Device Description
The Saturn 9000-810 is equipped with a digital detector. X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the X-ray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-810 includes acquisition workstation ("AWS") monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.
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K Number
K072984Device Name
SATURN 9000-550
Manufacturer
NEW MEDICAL CO., LTD.
Date Cleared
2007-11-14
(22 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
NEW MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Saturn 9000-550 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-550 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-550 is intended to be used in same clinical application as traditional film-screen based general radiography system.
Device Description
The Saturn 9000-550 is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the Xray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-550 includes acquisition workstation ("AWB") monitor, keyboard and mouse, computer, electronics, and accessory storage. resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.
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K Number
K072983Device Name
SATURN 9000-750
Manufacturer
NEW MEDICAL CO., LTD.
Date Cleared
2007-11-13
(21 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
NEW MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Saturn 9000-750 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-750 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-750 is intended to be used in same clinical application as traditional film-screen based general radiography system.
Device Description
The Saturn 9000-750 is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the Xray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-750 includes acquisition workstation ("AWB") monitor, keyboard and mouse, computer, electronics, and accessory storage resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.
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K Number
K063710Device Name
SATURN 9000
Manufacturer
NEW MEDICAL CO., LTD.
Date Cleared
2007-07-16
(214 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
NEW MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Saturn 9000 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000 is intended to be used in same clinical application as traditional film-screen based general radiography system.
Device Description
The Saturn 9000 Is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the X-ray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000 includes acquisition workstation ("AWS") monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites. and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming,
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