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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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Clear Guide CORE - B201CGCORE24MR0

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

Clear Guide CORE - B201CGCORE240

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

BeamSite - 00860009184503

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

Clear Guide CORE - B201CGCORE130

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

CapsoCloud - 00867770000223

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

True 3D Viewer - 00851325007003

Software: The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.
ECHOPIXEL, INC.
EP-00003
In Commercial Distribution

  • 00851325007003 ()
SW-0001-1601

  • Radiology picture archiving and communication system workstation
  • Radiology DICOM image processing application software

Ashvins - 04260648620053

No Description
MedicalCommunications GmbH
2023 (Build 2167)
In Commercial Distribution

  • 04260648620053 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software

Ashvins variant HEYEX 2 / HEYEX PACS - 04260648620046

No Description
MedicalCommunications GmbH
2.6
In Commercial Distribution

  • 04260648620046 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software

Ashvins - 04260648620039

No Description
MedicalCommunications GmbH
2023 (Build 2088)
In Commercial Distribution

  • 04260648620039 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software

Ashvins variant Diagnostic Workstation, Ashvins variant Image & Web Management - 04260648620008

No Description
MedicalCommunications GmbH
Ashvins 2020
In Commercial Distribution

  • 04260648620008 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
  • Ophthalmology PACS software
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