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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MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT Web app 1.1
In Commercial Distribution

  • 05056190500887 ()
MapRT Web app

  • Radiation therapy software
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT Web app
In Commercial Distribution

  • 05056190500771 ()
MapRT Web app

  • Radiation therapy software
No Description
Ventric Health
VA 1.0
In Commercial Distribution

  • 00850044849024 ()


  • Cardiac mapping system application software
physIQ Medical Device Data System Android App
PHYSIQ, INC
3.4 (Edison)
In Commercial Distribution

  • 00860004366218 ()


  • Electrocardiography telemetric monitoring system
This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software
The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.
Persyst Development Corp
Persyst Mobile App
In Commercial Distribution

  • 00869732000135 ()


  • Bioelectrical signal analysis software
SW, EXE, Lifeline Response Smart Phone Application, Google
Lifeline Systems Company
300000161331
Not in Commercial Distribution

  • 00884838082137 ()
mSafe

  • Vulnerable patient home alert system
SW, EXE, Lifeline Response Smart Phone Application, Apple
Lifeline Systems Company
300000161311
Not in Commercial Distribution

  • 00884838082120 ()
mSafe

  • Vulnerable patient home alert system
No Description
ECENTIAL ROBOTICS
L60018
In Commercial Distribution

  • 03701311501497 ()


  • Robotic surgical navigation system application software
No Description
Carl Zeiss Meditec AG
FORUM Viewer App
In Commercial Distribution

  • 04049471100020 ()


  • Patient health record information system application software
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400052
In Commercial Distribution

  • J00714000520521 ()
1400052

  • Surgical power tool system control unit, line-powered
  • Dental treatment application software
myCordella Patient App is a component of the myCordella Patient Kit. myCordella Patient App is an intuitive, user-friendly software that assists patients with obtaining vital sign measurements. • Collects & securely transmits daily health information to clinicians • Facilitates review of past measurements • Allows secure communication between patient and clinician
Endotronix, Inc.
100256-02
In Commercial Distribution

  • 00850008997037 ()


  • Bedside monitor remote-viewing software, physiological parameter
No Description
Cochlear Bone Anchored Solutions AB
P1646035
In Commercial Distribution

  • 09321502053006 ()
P1646035

  • Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646054
In Commercial Distribution

  • 09321502052993 ()
P1646054

  • Audiometric/hearing device software
iOS version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078962 ()
P1646054

  • Audiometric/hearing device software
Android version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078955 ()
P1646035

  • Audiometric/hearing device software
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
2.0
In Commercial Distribution

  • D16420251 ()


  • CAD/CAM software
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
0.9.6
In Commercial Distribution

  • D16409625 ()


  • CAD/CAM software
DreamMapper iOS NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051331 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049932 ()
1101478

  • Self-care monitoring/reporting software
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