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Found 12 results
510(k) Data Aggregation
K Number
K233693Device Name
Nio Color 8MP (MDNC-8132)
Manufacturer
Barco N.V.
Date Cleared
2023-12-11
(24 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Barco N.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Device Description
The No Color 8MP (MDNC-8132) is a medical computer display designed for general radiology applications. The device can also be used for home reading in radiology. The display is a high-resolution LCD monitor with characteristics that are important for accurate medical image review: high luminance, good luminance uniformity, good luminance stability. The medical display comes with special image-enhancing technologies to ensure consistent brightness over the display, noise-free images (=good luminance uniformity), ergonomic reading and automated compliance with DICOM and other medical image quality standards and guidelines. These technologies help the radiologist to make a swift and accurate diagnosis. The displays can be used optionally with the downloadable QAWeb Enterprise software, listed under D332294 as a class 1 device with product code LHO. QAWeb Enterprise is a calibration software that is intended as a quality assurance software for the displays. QAWeb Enterprise software helps to keep the display DICOM compliant. The display can be used optionally with the downloadable Intuitive Workflow Tools, cleared in K191845 as a class 2 device with product code PGY. The Intuitive Workflow Tools are accessories for image enhancement on diagnostic displays: SpotView and AAM – Application Appearance Manager. The display can be used with or without the Barco MXRT display controller boards.
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K Number
K173381Device Name
Nexxis OR
Manufacturer
Barco n.v.
Date Cleared
2018-02-22
(115 days)
Product Code
DXJ
Regulation Number
870.2450Why did this record match?
Applicant Name (Manufacturer) :
Barco n.v.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room.
The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface signals and control signals of non-medical room equipment,
The Barco Nexxis OR system allows control and selection of these signals from a central point.
The Barco Nexxis OR system is not intended to be used for remote or robotically assisted surgery,
The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other devices that use strong magnetic fields.
Device Description
The Nexxis OR system is a solution for video distribution in operating rooms and medical procedure laboratories. The Nexxis OR can consist of any possible combination of the Nexxis encoders/decoders that transfer video signals from various available devices to one or more output devices (displays). Additionally the Nexxis components can transfer audio signals and USB signals. The USB communication is intended only for keyboard and mouse control and control signals for non-medical room equipment. The selection of sources and output devices is done by control software (NMS API). The Nexxis OR system can also contain, optionally, the MNC-180 compositor device, a MDSC-8258 MNA display and/or the touch user interface MUIP-2112. The Nexxis OR system may now consist of any combination of the following components: a) Nexxis OR components (Medical network adaptors) b) Nexxis Compositor with NCS composition software (MNC-180) c) Nexxis Management Suite (NMS). d) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA.(optional) e) touch user interface MUIP-2112 (optional) f) Cables g) Documentation
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K Number
K172922Device Name
MMPC-4127F1
Manufacturer
Barco N.V.
Date Cleared
2017-12-21
(87 days)
Product Code
PZZ
Regulation Number
864.3700Why did this record match?
Applicant Name (Manufacturer) :
Barco N.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners that have been validated for use with this device, for review and interpretation by pathologists. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
Device Description
The MMPC-4127F1, also marketed as the PP27QHD, is a stabilized, color-calibrated display system designed to review and interpret digital images of surgical pathology slides.
The display is equipped with a 27-inch color LCD panel with a fine pixel pitch that can be calibrated to the sRGB gamut.
Accessories:
- QAWeb quality assurance software
- DisplayPort cable
- USB cable
- AC power cord cables
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K Number
K170537Device Name
Nexxis OR, Nexxis
Manufacturer
Barco n.v.
Date Cleared
2017-04-21
(57 days)
Product Code
DXJ
Regulation Number
870.2450Why did this record match?
Applicant Name (Manufacturer) :
Barco n.v.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room.
The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface signals and control signals of non-medical room equipment,
The Barco Nexxis OR system allows control and selection of these signals from a central point.
The Barco Nexxis OR system is not intended to be used for remote or robotically assisted surgery,
The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other devices that use strong magnetic fields.
Device Description
The generic Nexxis OR system is a solution for video distribution in operating rooms and medical procedure laboratories. The generic nexxis OR can consist of any possible combination of the nexxis encoders/decoders that transfer video signals from various available devices to one or more output devices (displays). Additionally the nexxis components can transfer audio signals and USB signals. The USB communication is intended only for keyboard and mouse control and control signals for non-medical room equipment. The selection of sources and output devices is done by control software (NMS API). The generic Nexxis OR system can also contain, optionally, the MNC-180 compositor device and/or a MDSC-8258 MNA display. The Nexxis OR system may consist of any combination of the following components: a) Nexxis OR components (MNA adapters (encoders and decoders), NMS management SW, network switches, SFP+ modules) b) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA. (optional) c) Nexxis Compositor (MNC-180) (optional) d) Cables e) Documentation
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K Number
K161880Device Name
NIVR58-T kit
Manufacturer
Barco N.V.
Date Cleared
2017-03-14
(249 days)
Product Code
DXJ
Regulation Number
870.2450Why did this record match?
Applicant Name (Manufacturer) :
Barco N.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The kit is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display.
Device Description
The NIVR58-T kit is a set of devices bundled together by Barco as a system, to be used in a larger system of a customer.
The system that Barco composes, consists of the following devices:
a) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA.
b) Nexxis Compositor (MNC-180)
c) Nexxis OR components
d) A control unit panel PC (tablet PC): Barco MTPP-0212 (other name: Proscribe) with control user interface.
e) Cables
f) Documentation
The NIVR58-T kit is the visualization part in an operating room or cathlab. The video sources from different medical devices in the OR are connected to the NIVR58-T kit. The NIVR58-T kit makes a composition of the video signals and sends the composition signals to the 58-inch display.
The selection of the video sources that have to be displayed and the layout of the composition is done by the Nexxis OR component and controlled by the control unit MTTP 0212, on which a Graphical User Interface is installed.
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K Number
K161229Device Name
Mammo Tomosynthesis (MDMG-5221)
Manufacturer
BARCO N.V.
Date Cleared
2016-05-18
(16 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BARCO N.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners.
It is specially designed for breast tomosynthesis applications.
Device Description
MDMG-5221, system name Barco Mammo Tomosynthesis, is an update of the 5MP display, specifically addressing the requirements of the emerging modality of Digital Breast Tomosynthesis (DBT) and QA software.
The display controller board is installed in a PACS workstation computer, connected to the display. The QA software helps to make and keep the displays DICOM compliant.
The display uses LED backlight technology.
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K Number
K151505Device Name
Coronis Uniti
Manufacturer
Barco N.V.
Date Cleared
2015-07-17
(43 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Barco N.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MDMC - 12133 is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners.
It is especially designed for breast tomosynthesis (3D mammography) applications, breast US.
It is especially designed for CT and ultrasound including vascular and gynecological US.
Device Description
Not Found
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K Number
K133994Device Name
SIVR56-T KIT
Manufacturer
BARCO N.V.
Date Cleared
2014-12-01
(340 days)
Product Code
DXJ
Regulation Number
870.2450Why did this record match?
Applicant Name (Manufacturer) :
BARCO N.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SIVR56-T KIT is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display.
Device Description
Not Found
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K Number
K141428Device Name
MDMC-12133
Manufacturer
BARCO N.V.
Date Cleared
2014-06-27
(28 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BARCO N.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MDMC-12133 is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is especially designed for breast tomosynthesis applications.
Device Description
Not Found
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K Number
K133663Device Name
NIO COLOR 2MP
Manufacturer
BARCO N.V.
Date Cleared
2014-03-25
(116 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BARCO N.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NIO 2MP LED Display (MDNC-2221) is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
Device Description
Nio Color 2MP (MDNC-2221)
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