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510(k) Data Aggregation
K Number
K162224Device Name
ArtPix Mobile EZ2GO
Manufacturer
CMT MEDICAL TECHNOLOGIES, LTD.
Date Cleared
2016-09-22
(45 days)
Product Code
KPR, MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
CMT MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ArtPix Mobile EZ2GO, is intended for use in general radiographic examinations by qualified/trained doctors or technicians, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography.
ArtPix Mobile EZ2GO allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Device Description
The modified ArtPix Mobile EZ2GO is a flexible high-resolution Digital Radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patient Imaging. The modified ArtPix Mobile EZ2GO consists of the following components: Tablet Computer, Flat Panel Detectors, Detector Removable batteries & Charger, and other optional components such as External Monitor for Docking Station, USB HUB, Bluetooth DAP device and Fix Room Access Point Support. Images may be transferred via a network using DICOM protocol for printing and storage in PACS.
The modified ArtPix Mobile EZ2GO can be used in combination with any conventional analog radiography system currently using film screen or CR, fixed or mobile, or other system capable of producing general radiography exposures.
The modified Artpix Mobile EZ2GO detector can be shared between multiple Artpix Mobile EZ2GO systems.
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K Number
K110849Device Name
PRESTODR 4143
Manufacturer
CMT MEDICAL TECHNOLOGIES, LTD.
Date Cleared
2011-04-26
(29 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
CMT MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PrestoDR 4143, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR 4143 allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
Device Description
The PrestoDR 4143 is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) and CMT's proprietary technology, which incorporates state of the art objectoriented software and connectivity. The legally marketed PrestoDR Portable K 100400 has been modified: To integrate the Pixium 4143 flat panel digital detector (FPD), improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions, intended use and principle of operation were not changed.
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K Number
K103038Device Name
DUET DRF
Manufacturer
CMT MEDICAL TECHNOLOGIES, LTD.
Date Cleared
2011-03-29
(166 days)
Product Code
JAA, REG
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
CMT MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Duet DRF is a digital image acquisition system to be used in conjunction with a solid state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use
Device Description
The Duet DRF is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) same as in K080859 DRF 4343, Villa sistemi medicali S.p.A. (this is the 510(k) for the system that incorporate the same flat panel detector and state of the art object-oriented software and connectivity.
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K Number
K100400Device Name
PRESTODR PORTABLE
Manufacturer
CMT MEDICAL TECHNOLOGIES, LTD.
Date Cleared
2010-04-22
(65 days)
Product Code
IZL, MOB
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
CMT MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PrestoDR Portable ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
Device Description
The PrestoDR Portable is a Digital Radiography system, featuring an integrated portable flat panel digital detector (FPD) K090625 WIRELESS PORTABLE DETECTOR FD-W17, Philips Medical Systems North America CO (this is the 510(k) for the wireless portable flat panel detector) and CMT's proprietary technology, which incorporates state of the art object-oriented software and connectivity. The legally marketed SMARTRAD K003438 has been modified: To integrate the portable flat panel digital detector (FPD) K090625, improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.
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K Number
K080890Device Name
SMARTSPOT PRIMAX
Manufacturer
CMT MEDICAL TECHNOLOGIES, LTD.
Date Cleared
2008-04-29
(29 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CMT MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Road mapping and DSA, that were not possible with conventional technique. Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies
Device Description
The SmartSPOT PrimaX is a high-resolution digital imaging system designed for Digital Spot Imaging. The system is based on a PC Workstation running Windows XT as the operating system. The legally marketed SMARTSPOT K961307 has been modified: To improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.
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K Number
K003438Device Name
SMART RAD
Manufacturer
CMT MEDICAL TECHNOLOGIES, LTD.
Date Cleared
2001-07-03
(239 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
CMT MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001111Device Name
PANORET, MODEL 1000A
Manufacturer
CMT MEDICAL TECHNOLOGIES, LTD.
Date Cleared
2000-07-07
(92 days)
Product Code
HKL
Regulation Number
886.1780Why did this record match?
Applicant Name (Manufacturer) :
CMT MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991578Device Name
SMARTSPOT 2000
Manufacturer
CMT MEDICAL TECHNOLOGIES, LTD.
Date Cleared
1999-06-03
(28 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CMT MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmartSpot 2000 is indicated for the acquisition, storage, processing (enhancement), printing and display of fluoroscopic and digital x-ray spot images.
Device Description
Not Found
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K Number
K961140Device Name
FLUOROPLUS CARDIAC TV
Manufacturer
CMT MEDICAL TECHNOLOGIES, LTD.
Date Cleared
1996-09-20
(183 days)
Product Code
JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
CMT MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961307Device Name
SMART SPOT
Manufacturer
CMT MEDICAL TECHNOLOGIES, LTD.
Date Cleared
1996-07-01
(88 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CMT MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SMARTSPOT enhances the quality of the fluoroscopy image, enables acquisition and display of high resolution (1024 x 1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Roadmapping and DSA, that were not possible with conventional techniques.
Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies.
Device Description
The SMARTSPOT is a high resolution digital system for Digital Spot Imaging in Radiography/Fluoroscopy (R/F) X-ray rooms. It is designed to reduce (and even replace) the use of cassette filming and 105 mm spot cameras, and in this way reduce overall patient radiation exposure and examination time.
The system is based on a computer workstation running Windows NT as the operating system. The other main components are: a high resolution CCD camera, an advanced video processor, operation room and control room monitors, X-ray and TV interfaces, Hardcopy Laser Camera interface and a 2 GBytes internal hard disk.
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