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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 Class Implantable

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EVA SELECT DIRECT SIZE 2 SYSTEM
ImageWorks
9992413200
In Commercial Distribution

  • D83399924132000 ()
9992413200

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution

  • B3945000001120 ()
500-0001-12

  • Multiple vital physiological parameter monitoring system, clinical
  • Multiple-patient intensive/general healthcare physiologic monitoring system
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution

  • B3945000001010 ()
500-0001-01

  • Multiple-patient intensive/general healthcare physiologic monitoring system
  • Multiple vital physiological parameter monitoring system, clinical
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOHM
In Commercial Distribution

  • B201CGOHM0 ()
  • B201CGOHM1 ()
CG-OH-M

  • Radiological video camera patient positioning/tracking system camera
  • Optical surgical navigation device tracking system
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOH
In Commercial Distribution

  • B201CGOH1 ()
  • B201CGOH0 ()
CG-OH

  • Radiological video camera patient positioning/tracking system camera
  • Optical surgical navigation device tracking system
The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software (SW) is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios CSM SW receives, stores, manages, and displays patient physiological and waveform data, and alarms generated by Vios proprietary patient vitals monitoring software. The Vios CSM SW is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
CSM2050 Software
In Commercial Distribution

  • B595CSM20500 ()
CSM2050

  • Centralized patient monitor
  • Cardiac arrhythmia monitoring system
  • Multiple vital physiological parameter monitoring system, clinical
  • Pulse oximeter
  • Clinical management support software
RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform. The software allows digital image processing, measurement, communication. and storage. RamSoft PACS is tested according to the specifications that are documented in a RamSoft PACS System Test Plan. Testing is an integral part of RamSoft's software development process. The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.
Ramsoft Inc
6.0.11.11031B
In Commercial Distribution

  • B359PSPACS6PRU11B0 ()
PSPACS6PRU11B

  • Radiology information system
  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
VERDURE IMAGING, INC.
000010
In Commercial Distribution

  • G618000010 ()


  • Ultrasound imaging system operation software
  • Hand-held ultrasound imaging system, body-surface
  • Ultrasound imaging system operator console
V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent.
VIATRONIX INCORPORATED
2.1
In Commercial Distribution

  • B209CAS2X10 ()


  • Radiological PACS software
V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent.
VIATRONIX INCORPORATED
2.0
In Commercial Distribution

  • B209CAS2X00 ()


  • Radiological PACS software
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