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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Endodrill Drive System is to be used with Endodrill Biopsy Instrument GI . Endodrill System is a surgical instrument used together with a flexible ultrasound endoscope to collect tissue for histological examination.
Bibbinstruments AB
Model X
In Commercial Distribution

  • 17340179900078 ()
3000-01

  • General-purpose endoscopic needle, single-use
SW000795 NGTELL7x-S Telligence Bridge Software, v7.4+
Ascom (Sweden) AB
7.x
In Commercial Distribution

  • 17350088671426 ()


  • Nurse call system
CT LVAS (CT:V) software is a non-invasive image processing technology that utilizes a paired inspiration-expiration CT to quantify and visualize regional and global ventilation within the lungs. The device provides physicians with additional clinical data to support management of pulmonary disease. Quantification and visualizations are provided in the form of a report.
4DMEDICAL LIMITED
1.x
In Commercial Distribution

  • 19356870000021 ()


  • CT system application software
No Description
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Navi X
In Commercial Distribution

  • 06971355420062 ()


  • General-purpose ultrasound imaging system
NEEDLE HOLDER TROUTMAN W/LOCK
Bausch & Lomb Incorporated
E3839 X
In Commercial Distribution

  • 00757770429882 ()


  • Suturing needle holder, reusable
NEEDLE HOLDER CURVED STORZ
Bausch & Lomb Incorporated
E3797 X
In Commercial Distribution

  • 00757770415205 ()


  • Suturing needle holder, reusable
The Web Diagnostic Viewer is the radiologist diagnostic workstation including the clinical applications (implemented using Web technology) with similar functionality as the Desktop Diagnostic Viewer workstation.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution

  • 00884838107588 ()
839063

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
The Desktop Diagnostic Viewer is the end user’s primary user interface used to interact with clinical images. It includes the clinical applications.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution

  • 00884838107571 ()
839062

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
v2.x
In Commercial Distribution

  • 00884838087958 ()
45980141116X

  • Radiology picture archiving and communication system workstation
Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system.
Philips Medical Systems Nederland B.V.
3.x
In Commercial Distribution

  • 00884838085640 ()
760001

  • Microscope slide digital imaging scanner IVD
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
9.x
Not in Commercial Distribution

  • 00884838075894 ()


  • Radiology DICOM image processing application software
Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. Philips IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. Philips IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.
Philips Medical Systems Nederland B.V.
8.x
In Commercial Distribution

  • 00884838074804 ()
837509

  • Radiology picture archiving and communication system workstation
I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. I4 (Integrated Intelligent Imaging Informatics) is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. I4 integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
1.x
In Commercial Distribution

  • 00884838074743 ()


  • Radiology picture archiving and communication system workstation
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
8.x
Not in Commercial Distribution

  • 00884838073876 ()


  • Radiology DICOM image processing application software
The Enterprise Viewer is used for image distribution within the enterprise. It is used by clinicians as the primary user interface to view and interact with images. It is also used by Radiologists as a lightweight form to access images where they don’t have access to the complete diagnostic workstations. Enterprise Viewer is accessed through an HTML5 browser either over a desktop or using a capable mobile device.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution

  • 00884838107595 ()
839064

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution

  • 00884838107557 ()
839060

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
No Description
Philips Electronics Nederland B.V.
1.1.X
Not in Commercial Distribution

  • 00884838098244 ()
821401000000

  • Cognitive assessment software
Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic system to produce controlled signals to perform audiometric evaluation and to assist in the diagnosis of otological disorders
KOALYS TECHNOLOGIES LTD
2.X
In Commercial Distribution

  • 07290017820019 ()
N/A

  • Tone audiometer
No Description
Changzhou Sifary Medical Technology Co., Ltd.
Ultra X
In Commercial Distribution

  • 06972597781171 ()


  • Ultrasonic dental scaling/debridement system
CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure. The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas). CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope. The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement.
ODIN MEDICAL LIMITED
v1.4.x
In Commercial Distribution

  • 15065010840024 ()


  • Endoscopic video image interpretive software
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