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Found 6 results
510(k) Data Aggregation
K Number
K023227Device Name
USG 2000SA
Manufacturer
ULTRAGUIDE LTD.
Date Cleared
2002-10-22
(25 days)
Product Code
HHJ
Regulation Number
884.2225Why did this record match?
Applicant Name (Manufacturer) :
ULTRAGUIDE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UltraGuide USG 2000sa system is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system.
The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.
Device Description
The UltraGuide USG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the ultrasound scan image of the internal organs, all displayed on the monitor of a personal computer.
The device uses magnetic transmitters and receivers, sold under the trade name "PC Birds," to determine the location and orientation of the interventional needle. These devices have been used on medical devices cleared by the FDA. The positions and orientations of the interventional device and the video of the US image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.
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K Number
K022354Device Name
ULTRAGUIDE CTG 2000SA
Manufacturer
ULTRAGUIDE LTD.
Date Cleared
2002-08-13
(25 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
ULTRAGUIDE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CTG 2000sa system is a stereotactic accessory for Computed Tomography (CT) systems. It displays the simulated image of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the CT image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient.
The device is intended to be used in clinical applications and for anatomical structures where computed tomography is currently used for visualizing such procedures.
Device Description
The CTG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the CT image of the internal organs, all displayed on the monitor of a personal computer.
The device uses magnetic transmitters and receivers, sold under the trade name "PC Birds," to determine the location and orientation of the interventional needle. These devices have been used on medical devices cleared by the FDA. The positions and orientations of the interventional device, and the video of the CT image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.
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K Number
K013150Device Name
MR-GUIDE 2000
Manufacturer
ULTRAGUIDE LTD.
Date Cleared
2001-10-18
(28 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
ULTRAGUIDE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic Resonance (MR) systems. The system is MRI-compatible. It displays the simulated image of a rigid insertion instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the MR image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient.
The device is intended to be used in clinical interventions and for anatomical structures where magnetic resonance is currently used for visualizing such structures.
Device Description
The MR-Guide 2000 provides visual guiding information of the interventional instrument by overlaying graphics depicting its relative position and its predicted future path on the MR image of the internal organs all displayed on the monitor of a personal computer.
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K Number
K011418Device Name
ULTRAGUIDE MR-GUIDE 3000
Manufacturer
ULTRAGUIDE LTD.
Date Cleared
2001-05-24
(15 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
ULTRAGUIDE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002258Device Name
ULTRAGUIDE CT-GUIDE 1010
Manufacturer
ULTRAGUIDE LTD.
Date Cleared
2000-08-08
(14 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
ULTRAGUIDE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K974432Device Name
ULTRAGUIDE 1000
Manufacturer
ULTRAGUIDE LTD.
Date Cleared
1998-02-09
(77 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
ULTRAGUIDE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UltraGuide 1000 system is indicated for enhancing the ultrasonic image of an interventional needle or needlelike rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.
Device Description
The UltraGuide 1000 provides visual enhancement of the interventional needle by overlaying the image of insertion device and its predicted future path on the insertion action and of the internal organs, all displayed on the monitor of a personal computer. The device uses magnetic transmitters and receivers, sold under the trade name "MiniBirds," to determine the location and orientation of the ultrasound scan head and the interventional needle. The positions and orientations of the interventional device, and the video of the ultrasound image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.
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