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Found 6 results
510(k) Data Aggregation
K Number
K000221Device Name
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
Manufacturer
GE DEC MEDICAL SYSTEMS
Date Cleared
2000-04-11
(78 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
GE DEC MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993687Device Name
UROVIEW 2800
Manufacturer
GE DEC MEDICAL SYSTEMS
Date Cleared
1999-12-21
(50 days)
Product Code
OWB
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
GE DEC MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include but are not limited to urologic and endoscopic procedures. The system may be used for other imaging applications at the physician's discretion.
Device Description
The UroView 2800 is a fluoroscopic x-ray system including a tilting patient-support table with overhead x-ray tube assembly, high-voltage x-ray generator, image intensifier, and video image display. A separate mobile workstation provides digital image processing, image storage capability, and additional video display.
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K Number
K992506Device Name
MINI 6800 DIGITAL MOBILE C-ARM
Manufacturer
GE DEC MEDICAL SYSTEMS
Date Cleared
1999-08-19
(23 days)
Product Code
OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
GE DEC MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MINI 6800 Digital Mobile C-arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.
Device Description
The OEC mobile workstation, which supports image display monitors, image processing and recording devices, is combined with a miniature C-arm to create the MINI 6800 Digital Mobile C-arm.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for North American markets, CCIR format for international markets, and DICOM 3.0.
The MINI 6800 has the following physical characteristics:
- . All components are contained in one mobile workstation.
- . An articulating arm is attached to the workstation and extends out from the main cabinet to position the x-ray imaging components.
- . All mechanical positioning of the workstation and articulating arm is manual (nonmotorized).
- . The system is powered by a non-detachable power cord.
- Power ratings between 100-240 VAC, 4-6 Amps at 50/60 Hz. .
- . Internal system power is insulated from input power by an isolation transformer.
- Fluoroscopic operation: .
- -- 40 to 80 kVp
- -- 20 to 160 µA (0.020 to 0.160 mA)
- Automatic Exposure Rate Control
Major components of the system include:
- Dual video monitors .
- Input isolation transformer .
- Digital image processing and x-ray control .
- Monoblock X-ray tube and high-voltage power supply .
- lmage intensifier ●
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K Number
K974355Device Name
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
Manufacturer
GE DEC MEDICAL SYSTEMS
Date Cleared
1998-02-17
(90 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
GE DEC MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMDIS is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Device Description
The IMDIS is comprised of two mobile units: a C-arm stand and a workstation. The C-arm stand supports the high-voltage generator, x-ray controls, and a "C" shaped apparatus which supports an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The mobile workstation, supports image display monitors, image processing and recording devices.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DICOM 3.0. An auxiliary connection is provided for a Medrad angiographic injector system to facilitate synchronized acquisition of angiographic images during contrast media iniection.
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K Number
K970063Device Name
SERIES 7600 MOBILE DIGITAL C-ARM
Manufacturer
GE DEC MEDICAL SYSTEMS
Date Cleared
1997-03-11
(63 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
GE DEC MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Series 7600 Mobile Digital C-arm is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Device Description
The Series 7600 system is comprised of two mobile units: the C-arm unit supports the high-voltage generator, x-ray components and x-ray controls; and the other unit, a mobile workstation, supports image display monitors, image processing and recording devices. The C-arm includes a "C" shaped arm that supports an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient.
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K Number
K963952Device Name
SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
Manufacturer
GE DEC MEDICAL SYSTEMS
Date Cleared
1996-12-23
(82 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
GE DEC MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Series 9600 Mobile Digital Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Device Description
The Series 9600 system is comprised of two mobile units: the C-arm unit supports the high-voltage generator, x-ray components and x-ray controls; and the other unit, a mobile workstation, supports image display monitors, image processing and recording devices. The C-arm includes a "C" shaped arm that supports an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DICOM 3.0.
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