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Found 13 results
510(k) Data Aggregation
K Number
K112180Device Name
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)
Manufacturer
INFIMED, INC.
Date Cleared
2011-08-10
(13 days)
Product Code
OWB, IZI, JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
INFIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InfiMed i*™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The iSm Digital X-78V Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The ism Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.
For the DR application, the InfiMed i *** Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluorosopy, angiography, and mammography).
For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or anglography imaging procedures are performed.
Device Description
The InfiMed i*™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i-TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.
The modified InfiMed i'm Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, DRTECH FLAATZ 560, Samsung SDX-4336CP), computer, monitor, and the digital imaging system.
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K Number
K111344Device Name
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
Manufacturer
INFIMED, INC.
Date Cleared
2011-06-10
(29 days)
Product Code
OWB, IZI, JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
INFIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InfiMed i5TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i5TM Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i5TM Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.
For the DR application, the InfiMed i5TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
For the RF/DSA application, the InfiMed i5TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
Device Description
The InfiMed i5TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i5TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.
The modified InfiMed i5TM Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, DRTECH FLAATZ 560), computer, monitor, and the digital imaging system.
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K Number
K103416Device Name
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
Manufacturer
INFIMED, INC.
Date Cleared
2011-03-17
(115 days)
Product Code
OWB, JAA, MQB
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
INFIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InfiMed i one Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i2M Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i2m Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.
For the DR application, the InfiMed i-714 Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography),
For the RF/DSA application, the InfiMed i TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
Device Description
The InfiMed i-TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i?™ Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.
The modified InfiMed ism Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, Trixell Pixium RF4343), computer, monitor, and the digital imaging system.
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K Number
K101833Device Name
INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
Manufacturer
INFIMED, INC.
Date Cleared
2010-07-23
(22 days)
Product Code
OWB, JAA, MQB
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
INFIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InfiMed i5m Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i5m Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i2m Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.
For the DR application, the InfiMed i-714 Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
Device Description
The InfiMed i m Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i-1 Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platforms.
The modified InfiMed if me Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R), computer, monitor, and the digital i maging system. The InfiStitch for i-m Digital X-ray Imaging System is an option which allows the operator to generate sequential radiographic images and electronically jointhum to create a single electronic image. This feature will be available for any InfiMed customer utilizing the i-The Digital X-ray Imaging System DR application on any flat parel detector.
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K Number
K093066Device Name
I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
Manufacturer
INFIMED, INC.
Date Cleared
2010-03-16
(167 days)
Product Code
OWB, IZI, JAA, MQB
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
INFIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InfiMed i5 TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i TM Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i5 TM Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.
For the DR application, the InfiMed i5 TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
For the RF/DSA application, the InfiMed i5 TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
Device Description
The InfiMed i5 TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i5 TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.
The InfiMed i5 TM Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A), computer, monitor, and the digital imaging system.
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K Number
K012490Device Name
ORION DIGITAL IMAGING SYSTEM
Manufacturer
INFIMED, INC.
Date Cleared
2002-02-12
(193 days)
Product Code
OWB
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
INFIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InfiMed Orion Fluoroscopic imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
Device Description
The Orion fluoroscopic imaging system allows the use of digital imaging to conventional X-ray system used in the general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging arcas. The system works by installing a CCD camera on the output of the image intensifier and digitizing the video output of the image intensifier. The digital image can then be displayed on the monitor, it can be stored to disk, or sent to an external device such as a laser imager or a DICOM network. The image can also be processed, including brightness and contrast, edge enhancement, zoom, and subtraction.
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K Number
K992392Device Name
RTLX
Manufacturer
INFIMED, INC.
Date Cleared
2000-03-31
(256 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
INFIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RTLX is a digital dental X-ray system with an intra-oral electronic sensor. Its intended use is to provide real-time x-ray images for dentists with a low X-ray dose By producing real-time imaging, the RTLX provides immediate information in the course of operative treatment, such as information on the position of instruments in internal structures.
Device Description
RTLX, for "Real-Time, Low-Intensity X-ray" is the first X-ray imaging system that provides capabilities for instant, full motion, digital radiographs designed specifically for the dental imaging marketplace. RTLX provides capabilities for X-ray generation, radiograph capture, image storage, and image display at up to 24 fps. The full motion, digital radiographs enhance a clinicians ability for "point-and-view" radiographs reducing patient X-ray exposure and time in the chair and improving speed and accuracy for procedure performance. Product appearance and mechanical structure is designed to provide a user friendly system for sensor placement and video control. In addition, printouts can be made of individual video frames.
The RTLX includes an X-ray source and X-ray sensor assembly for generation and acquisition of X-ray signals. Additionally, power and X-ray control electronics are provided, and an image processor is utilized for radiograph acquisition, processing, and display. Mechanical design emphasizes appearance and functionality. Switches, LEDs, and a printer are provided for user input and feedback.
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K Number
K992794Device Name
STINGRAY DR, MODEL 1
Manufacturer
INFIMED, INC.
Date Cleared
1999-11-09
(82 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
INFIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stingray DR Solid State X-ray Imaging Device is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography).
Device Description
The Stingray DR system uses a flat panel x-ray detector that contains a CsI Scintillator and a Amorphous Si TFT array for conversion of X-rays into an electronic digital image. This system is to be used as a replacement for Screen film x-ray devices for X-ray images. The Stingray DR system has a Personal computer that is used for image storage and retrieval and image processing. The system allows for post processing of images. This allows for the potential to use images that might have been useless if taken on film due to, for example, incorrect technique since the Stingray DR system can post process the images, modify the output look up table and possibly bring out data that could not be seen under normal circumstances.
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K Number
K992575Device Name
CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000
Manufacturer
INFIMED, INC.
Date Cleared
1999-10-07
(66 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
INFIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InfiMed Cardiovascular Workstation provides digital acquisition and review of cardiac images. The system can acquire images from a variety of sources ( including through DICOM transfer, real-time high resolution 1024 line analog secondary image capture and high speed direct digital connection). Patient images may be stored locally ( on hard drive, written to CD-R media and / or networks) or stored to permanent archive, using the DICOM standards. In addition, the Cardiovascular Workstation provides image review of patient studies in real-time or slow motion, as well as processing and analysis capability. Review functionality also includes multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras.
Device Description
The InfiMed Cardiovascular Workstation CWS 5000 provides digital acquisition and review of DICOM images. The CWS 5000 will acquire ACC/NEMA DICOM images or real-time, high resolution 1024 line analog secondary image capture. The CWS 5000 output is ACC/NEMA DICOM. Patient images may be written to CD-R media according to the ACC/NEMA DICOM standards for permanent archive and/or patient interchange. In addition, the CWS 5000 provides DICOM image review including multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras. The CWS 5000 is compatible with standard network technology and is conformant to DICOM standards.
The InfiMed Cardiovascular Workstation CWS 3000 provides DICOM image review including multi-modality imaging to support diagnosis and therapy of cardiovascular patients. Patient studies may be reviewed in real-time or slow motion using a knob on a dedicated cardiology remote control (optional). MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras. The CWS 3000 is compatible with standard network technology and is conformant to DICOM standards. In addition, the CWS 3000 is available with a high speed direct digital connection to the InfiMed Gold One for filmless operation including DICOM review, CD-R generation and networking.
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K Number
K962422Device Name
INFIMED DENTAL SYSTEM
Manufacturer
INFIMED, INC.
Date Cleared
1997-09-11
(444 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
INFIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InfiMed Dental System is an image acquisition and management system that allows acquisition, processing, display, and print of filmless radiographs and/or color dental images. It consists of various components that acquire, store, display, and print radiographs and/or color dental images with patient information.
Device Description
The InfiMed Dental System is an image acquisition and management system. Its capabilities include: Color image acquisition takes place from a standard S-video color camera. Radiograph acquisition takes place from a Charge Injection Device (CID) sensor custom designed for the application. Images can be directly printed and displayed on standard S-video equipment or transferred to a personal computer for acquisition and storage. If images are stored on the personal computer, dental image management software is utilized for patient data input, image processing, and image display on the computer monitor. In addition, printed reports are available from the personal computer.
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