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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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WVSM Management Suite - iOS
ATHENA GTX, INC.
iOS Software
In Commercial Distribution

  • B3943950006000 ()
395-0006-00

  • Centralized patient monitor
The Vios Monitoring System (VMS) Central Station Monitor (CSM)/Central Server (CS) Software (SW) is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM SW and CS SW receives, stores, manages and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software. The VMS CS SW acts as the server relay for the VMS system. It transmits, stores, and encrypts patient demographic and vitals data between multiple Vios Bedside Monitors (BSMs) to the Vios CSM. The Vios CS SW allows for retrieval of patient demographics, vitals and alarm data and product utilization through retrieval of audit logs. The Vios CS SW allows for creation and configuration of Monitoring Units (i.e. Wards), Caregivers, Departments, Rooms, Beds, and Default Monitoring Profiles for BSMs that are in Connected Mode.
MURATA VIOS, INC.
VCS2050 Software
In Commercial Distribution

  • B595VCS2050 ()
VCS2050

  • Network server
  • Cardiac arrhythmia monitoring 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
The Vios Monitoring System (VMS) Bedside Monitor (BSM) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected. The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions. The VMS BSM is intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
BSM2050 Software
In Commercial Distribution

  • B595BSM20500 ()
BSM2050

  • Pulse oximeter
  • General-purpose multi-parameter bedside monitor
  • Cardiac arrhythmia monitoring system
  • Pulse Co-oximeter probe, reusable
The nCommand Lite system is a SaMD (Software as Medical Device) that is customer-facing and provides remote access through a web application for viewing/reviewing images as well as the ability to remotely provide real-time guidance to the near-patient licensed technologist (local users) operating the medical imaging devices in the context of training, procedure assessment, for MRI, CT, and PETMedical image management and processing system CT scanner. Remote users are licensed technologists and are able to access an imaging medical device from a computer that meets the minimum required specifications anywhere, using a secure software connection that streams video and provides keyboard and mouse access. This allows remote users to assist local users, with both remote and local users' qualifications and responsibilities being subject to local regulations where the imaging occurs. This access must be granted by the local user using the system, and it can also be revoked at any time by the local user, thus allowing him/her to maintain complete control of the session at all times. Also, each remote session is controlled via a secure credential that is managed by the local user. Connections to a medical device are limited to one remote session at a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use. nCommand Lite is an IT hardware and software-based installation solution that supports multisession, allowing remote technologists to view multiple medical imaging devices as needed. However, access is restricted to one medical imaging device at any given time, as only one keyboard and one mouse are provided. Scanners that are compatible with nCommand Lite system comply with a common protocol, allowing for scanning parameter management and remote scanning.
IONIC HEALTH TECHNOLOGIES S/A
Software version
In Commercial Distribution

  • 07898974112002 ()


  • Radiology DICOM image processing application software
No Description
Novocure GmbH
NovoTAL Software
In Commercial Distribution

  • 07290107981729 ()
90094

  • Alternating electric field antimitotic cancer treatment system generator
No Description
Novocure GmbH
NovoTAL Software
Not in Commercial Distribution

  • 07290107981576 ()
90094

  • Alternating electric field antimitotic cancer treatment system generator
No Description
Novocure GmbH
NovoTAL Software
Not in Commercial Distribution

  • 07290107980715 ()
90094

  • Alternating electric field antimitotic cancer treatment system generator
No Description
BIO-VIEW LTD
Solo Software
In Commercial Distribution

  • 07290107653053 ()


  • Fluorescence light microscope
3DQuorum® is an image processing software application for post-processing tomosynthesis data captured on a Hologic tomosynthesis imaging system, into a combined 3D image.
Hologic, Inc.
3DQUORUM SOFTWARE
In Commercial Distribution

  • 15420045512313 ()
SW-05673

  • Stationary mammographic x-ray system, digital
No Description
Hologic, Inc.
System Software
In Commercial Distribution

  • 15420045504721 ()


  • Mammographic stereotactic biopsy system
Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3D software
In Commercial Distribution

  • 15420045500013 ()
SW-01648

  • Stationary mammographic x-ray system, digital
No Description
Hologic, Inc.
I-View Software
In Commercial Distribution

  • 15420045512658 ()
SW-03078

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3DIMENSIONS SOFTWARE
In Commercial Distribution

  • 15420045507296 ()
SW-04883

  • Stationary mammographic x-ray system, digital
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
MultiSoft software
In Commercial Distribution

  • EPTWS0900020 ()
S090002

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
PeakScan software
In Commercial Distribution

  • EPTWS0800520 ()
S080052

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
FilmScan software
In Commercial Distribution

  • EPTWS0800380 ()
S080038

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
MP1Control software
In Commercial Distribution

  • EPTWS0800310 ()
S080031

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
MP3Control software
In Commercial Distribution

  • EPTWS0800300 ()
S080030

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
TanSoft software
In Commercial Distribution

  • EPTWS0800280 ()
S080028

  • Multi-modality therapeutic radiation phantom, anthropomorphic
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