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Found 9 results
510(k) Data Aggregation
K Number
K123208Device Name
DIGITAL RETINAL CAMERA
Manufacturer
CANON, INC.-MEDICAL EQUIPMENT GROUP
Date Cleared
2013-03-19
(158 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
CANON, INC.-MEDICAL EQUIPMENT GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digital Retinal Camera CR-2 Plus AF is intended to be used for taking digital images of the retina of the human eye without a mydriatic. The CR-2 Plus AF has the following photography modes: color, red free, cobalt digital and fundus autofluorescence (FAF).
Device Description
The Digital Retinal Camera CR-2 Plus AF is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-2 Plus AF. Images can be viewed immediately, and procedures of imaging are more efficient with many different applications such as telemedicine and electronic filing. The CR-2 Plus AF is equipped with autofocus/automatic shooting/automatic switching function from anterior segment image to fundus image.
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K Number
K121303Device Name
MOBILE C-ARM
Manufacturer
CANON, INC.-MEDICAL EQUIPMENT GROUP
Date Cleared
2012-07-26
(86 days)
Product Code
OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
CANON, INC.-MEDICAL EQUIPMENT GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XEPHILIO MC-1100 mobile fluoroscopy system is designed to provide fluoroscopic and spot-film radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, 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 XEPHILIO MC-1100 mobile fluoroscopy system consists of two mobile units: a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports an X-ray tube and a flat panel detector [Canon CSX-10]. The Mainframe is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The Mainframe can be used to acquire both still and moving images. The Workstation is a mobile platform that supports image display monitors and image processing. Interfaces are provided for optional peripherals such as recording and printing devices.
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K Number
K111824Device Name
FLAT PANEL DETECTOR
Manufacturer
CANON, INC.-MEDICAL EQUIPMENT GROUP
Date Cleared
2012-04-23
(300 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
CANON, INC.-MEDICAL EQUIPMENT GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K111710Device Name
FULL AUTO TONOMETER MODEL TX-20
Manufacturer
CANON, INC.-MEDICAL EQUIPMENT GROUP
Date Cleared
2011-09-20
(92 days)
Product Code
HKX
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
CANON, INC.-MEDICAL EQUIPMENT GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Canon Full Auto Tonometer TX-20 is intended to be used for the measurement of intraocular pressure of the human eye.
Device Description
The Canon Full Auto Tonometer TX-20 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure with the help of a full auto-alignment system.
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K Number
K111682Device Name
DIGITAL RADIOGRAPHY
Manufacturer
CANON, INC.-MEDICAL EQUIPMENT GROUP
Date Cleared
2011-09-02
(79 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
CANON, INC.-MEDICAL EQUIPMENT GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DIGITAL RADIOGRAPHY CXDI-501G and CXDI-501C provide digital image capture for conventional film/screen radiographic examinations.
These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
These devices are not intended for mammography applications.
Device Description
The Digital Radiography CXDI-501G and CXDL-501C are solid state x-ray imagers which have 35.0 x 42.6 cm imaging area. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated it is converted to digital value. and the images will be displayed on monitors.
The CXDI-501G uses GOS (Gadolium Oxy-Sulfide) as the material for fluorescent screen, while CXDI-501C uses Csl (Cesium Iodide) which provides high x-ray absorption as fluorescent screen. Both models employ housing for easy installation in stand and table unit.
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K Number
K112309Device Name
DIGITAL RADIOGRAPHY
Manufacturer
CANON, INC.-MEDICAL EQUIPMENT GROUP
Date Cleared
2011-09-02
(22 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
CANON, INC.-MEDICAL EQUIPMENT GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXDI-80G Wireless provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.
Device Description
The DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXD1-80G Wireless are solid state x-ray imagers which have 27x35cm imaging area. The DIGITAL RADIOGRAPHY CXDI-80C/80G Wireless intercept x-ray photons and the scintillator of the CXDI-80C/80G Wireless emit visible spectrum phonomy photons and the array of photo-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors. The digital value can be communicated to the operator conselver wia wiring connection or wireless.
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K Number
K103591Device Name
DIGITAL RADIOGRAPHY
Manufacturer
CANON, INC.-MEDICAL EQUIPMENT GROUP
Date Cleared
2011-03-29
(112 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
CANON, INC.-MEDICAL EQUIPMENT GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DIGITAL RADIOGRAPHY CXDI-401G, CXDI-401C, CXDI-401G COMPACT and CXDI-401C COMPACT provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.
Device Description
The DIGITAL RADIOGRAPHY CXD1-401G CXD1-401C, CXD1-401G COMPACT and CXDI-401C COMPACT are solid state x-ray imagers which have 41.5 x 42.6cm imaging area. The device intercents x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors. The CXDI-401G and CXDI-401G COMPACT use GOS (Gadolium Oxy-Sulfide) as the material for fluorescent screen, while CXDI-401C and CXDI-401C COMPACT use Csl (Cesium Iodide) which provides high x-ray absorption as fluorescent screen. The CXDI-401G COMPACT and CXDI-401C COMPACT employ housing for easy installation in stand unit and table unit.
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K Number
K102013Device Name
DIGITAL RETINAL CAMERA
Manufacturer
CANON, INC.-MEDICAL EQUIPMENT GROUP
Date Cleared
2010-10-29
(105 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
CANON, INC.-MEDICAL EQUIPMENT GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to be used for taking digital images of the retina of the human eye without a mydriatic.
Device Description
The DIGITAL RETINAL CAMERA CR-2 is used for taking digital images of retina of human eye without a mydriatic. Canon EOS Digital Camera is mounted to the CR-2. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.
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K Number
K102012Device Name
DIGITAL RADIOGRAPHY
Manufacturer
CANON, INC.-MEDICAL EQUIPMENT GROUP
Date Cleared
2010-08-17
(32 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
CANON, INC.-MEDICAL EQUIPMENT GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DIGITAL RADIOGRAPHY CXD1-70C Wireless provides digital image capture for conventional film/screen radiographic examinations.
The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
This device is not intended for mammography applications.
Device Description
The DIGITAL RADIOGRAPHY CXDI-70C Wireless is a solid state x-ray imager which has approx. 35x43cm imaging area.
The DIGITAL RADIOGRAPHY CXD1-70C Wireless intercepts x-ray photons and the scintillator of the CXDI-70C Wireless emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals.
After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors. The digital value can be communicated to the operator console via wiring connection or wireless.
Ask a Question
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