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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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
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
The Vue PACS (Web Diagnostic) viewer is an add-on capability that allows running the diagnostic viewer capabilities from a web browser.
Philips Medical Systems Nederland B.V.
Vue PACS (Web Diagnostic) - 12
In Commercial Distribution

  • 00884838103504 ()
8986010

  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
Variety click SP Mini - 8, straight / Monoguided special expansion screw with click feature to prevent unwanted reversing / For further information please visit our online-
DENTAURUM GmbH & Co.KG
602-839-55
In Commercial Distribution

  • J011602839550 ()
  • J011602839551 ()


  • Orthodontic palate expander screw, bonded
Variety click SP Mini - 8, straight / Monoguided special expansion screw with click feature to prevent unwanted reversing / For further information please visit our online-
DENTAURUM GmbH & Co.KG
602-838-55
In Commercial Distribution

  • J011602838550 ()
  • J011602838551 ()


  • Orthodontic palate expander screw, bonded
BeamSite™ is a camera system that enables live visualization of the treatment beam on a patient during radiotherapy. It is an optically based system that is non-patient contacting and produces no radiation. When the treatment beam is on, BeamSite captures images of Cherenkov light emitted from the patient’s skin during radiotherapy to provide an optical map of the treatment beam on the patient. When the treatment beam is off, the system provided continuous background images of the treatment area under ambient light illumination. The BeamSite system consists of a camera, a workstation with preinstalled BeamSite software, and a monitor to be used by clinical radiotherapy teams to a) visually observe the patient and the Cherenkov light emitted from irradiated surface anatomy, and b) review the treatment images, if necessary.
Doseoptics LLC
BeamSite
In Commercial Distribution

  • 00860009184503 ()


  • Radiation therapy software
  • Radiation therapy system workstation, multi-purpose
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE13
In Commercial Distribution

  • B201CGCORE130 ()
  • B201CGCORE131 ()
CG-CORE-13

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Portable computer
Web-based software for managing the CapsoCam Plus procedures used by health care providers, readers, download centers, and upload centers, also providing online video reviewing and reporting functionalities.
CAPSOVISION, INC.
2
In Commercial Distribution

  • 00867770000223 ()
CLD

  • Video capsule endoscopy system application software
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