Search Results
Found 5 results
510(k) Data Aggregation
K Number
K083181Device Name
QV-9000 UNIVERSAL SYSTEM
Manufacturer
QUANTUM MEDICAL IMAGING, LLC.
Date Cleared
2008-11-26
(29 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM MEDICAL IMAGING, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QV-9000 Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.
Device Description
The QV-9000 Universal System is a stationary, general purpose, X-ray imaging system used for acquiring radiographic exposures of various parts of the body including the skull, spinal column, chest, thorax, abdomen and extremities. The QV-9000 Universal System incorporates a floor-mounted vertical support column, with an attached rotating 'C' arm, an image receptor, an X-ray tube and collimator. The QV-9000 Universal System is compatible for use with either a digital or non-digital (film type) image receptor cabinet
Ask a Question
K Number
K080905Device Name
QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI
Manufacturer
QUANTUM MEDICAL IMAGING, LLC.
Date Cleared
2008-07-16
(106 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM MEDICAL IMAGING, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum / Canon CXDI Integration System provides diagnostic quality images to aid the physician with diagnosis. The System can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The System is not indicated for use in mammography.
Device Description
The Quantum / Canon CXDI Integration System consists of add-on software that will allow the use of the currently marketed Quantum Q-Rad Radiographic System with the currently marketed Canon CXDI Series System, including models CXDI-40EG or CXDI-50G, as a fully integrated digital imaging system.
Ask a Question
K Number
K072010Device Name
QUANTUM DIREX SYSTEM
Manufacturer
QUANTUM MEDICAL IMAGING, LLC.
Date Cleared
2007-08-07
(15 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM MEDICAL IMAGING, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum DiRex System provides diagnostic quality images to aid the physician with diagnosis. The DiRex can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The DiRex is not indicated for use in mammography.
Device Description
The Quantum DiRex System is an integrated digital imaging system that combines the currently marketed Quantum Q-Rad Radiographic System with the currently marketed Agfa DX-S CR System (digitizer with NX workstation). The Quantum DiRex System is a combination of these previously cleared systems that have been combined and will be marketed as a single system.
Ask a Question
K Number
K023008Device Name
UNIVERSAL SYSTEM, MODEL QV-800
Manufacturer
QUANTUM MEDICAL IMAGING, LLC.
Date Cleared
2002-11-13
(65 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM MEDICAL IMAGING, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum Medical Imaging, LLC Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.
Device Description
The QV-800 Universal System is a walland floor-mounted column with an attached "swivel-arm". The QV-800 Universal System's "swivel-arm" design allows the x-ray tube and image receptor to remain in constant alignment as the arm is rotated and as the image receptor is anqulated. The QV-800 Universal System is designed for use in hospitals, imaging centers, and clinics.
Ask a Question
K Number
K011486Device Name
Q-RAD RADIOGRAPHIC SYSTEM
Manufacturer
QUANTUM MEDICAL IMAGING, LLC.
Date Cleared
2001-06-20
(36 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM MEDICAL IMAGING, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1