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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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myAir - 00840193400122

myAir (Android)
RESMED CORP.
22246
In Commercial Distribution

  • 00840193400122 ()
22246

  • Self-care monitoring/reporting software

myAir - 00840193400115

MYAIR FOR IOS APP
RESMED CORP.
22245
In Commercial Distribution

  • 00840193400115 ()
22245

  • Self-care monitoring/reporting software

OptimMRI (v2) - 03770021895035

OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest.
REBRAIN
v2.0.1
In Commercial Distribution

  • 03770021895035 ()


  • Stereotactic system application software

OptimMRI - 03770021895011

OptimMRI is a software application for processing medical images of the brain that enables 3D visualization and analysis of anatomical structures. Specifically, the software can be used to read DICOM compatible pre-operative MR images acquired by commercially available imaging devices. These images can be processed to generate 3D markers in specific regions of the anatomy to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan neurosurgical functional procedures. OptimMRI is used as an aid to localize regions of the brain such as Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM).
REBRAIN
v1.2.0
In Commercial Distribution

  • 03770021895011 ()


  • Stereotactic system application software

inHEART MODELS Shaper - 03770019599082

inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D models of the patient heart from medical images acquired by CT and/or MR devices. inHEART MODELS Shaper is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the users are solely responsible for making all final patient management decisions.
INHEART
v1.8.0
In Commercial Distribution

  • 03770019599082 ()


  • Image segmentation application software

inHEART MODELS AI - 03770019599075

inHEART MODELS AI is a medical image processing software for automatic 3D modelling, used to pre-process medical images (acquired only by CT devices). inHEART Models AI results are intended to be reviewed and, if needed, edited by inHEART trained staff with inHEART Models Shaper. inHEART MODELS AI is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
INHEART
v1.1.0
In Commercial Distribution

  • 03770019599075 ()


  • Image segmentation application software

inHEART Models Shaper - 03770019599037

inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D models of the patient heart from medical images acquired by CT and/or MR devices. inHEART MODELS Shaper is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the users are solely responsible for making all final patient management decisions.
INHEART
v1.4.0
Not in Commercial Distribution

  • 03770019599037 ()


  • Image segmentation application software

inHEART Models Shaper - 03770019599013

inHEART Models Shaper is a medical image processing and visualization software for manual 3D segmentation including cardiac images. It provides simple image review software functionality for basic medical image processing and manipulation, such as grayscale window and level, zoom and pan, image reformat, thresholding or user delineated geometric measurements (distance and volume). It is intended to be used by inHEART trained staffs. inHEART Models Shaper is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians). Clinicians are solely responsible for making all final patient management decisions.
INHEART
v1.2.0
Not in Commercial Distribution

  • 03770019599013 ()


  • Image segmentation application software

Polysmith Sleep System - 00841983104008

Polysomnography Sleep System Version 11
NIHON KOHDEN AMERICA, INC.
A/ONEBED-SCORE-11X
In Commercial Distribution

  • 00841983104008 ()
A/ONEBED-SCORE-11X

  • Sleep disorder interpretive software

Polysmith Sleep System - 00841983103148

Polysomnography Sleep System Version 10
NIHON KOHDEN AMERICA, INC.
A/ONEBED-SCORE-10X
In Commercial Distribution

  • 00841983103148 ()
A/ONEBED-SCORE-10X

  • Sleep disorder interpretive software

Polysmith Sleep System - 00841983103131

Polysomnography Sleep System Version 9
NIHON KOHDEN AMERICA, INC.
A/ONEBED-SCORE-9X
In Commercial Distribution

  • 00841983103131 ()
A/ONEBED-SCORE-9X

  • Sleep disorder interpretive software

DaTQUANT - 00195278011343

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
2.0
In Commercial Distribution

  • 00195278011343 ()


  • SPECT system application software

DIGITIVA Mobile Application - 00304692416447

Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Android devices.
Astellas Pharma Us, Inc.
Android (Version 1)
In Commercial Distribution

  • 00304692416447 ()
DIGI-002

  • Medication reminder application software

DIGITIVA Mobile Application - 00304692416089

Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices.
Astellas Pharma Us, Inc.
iOS (Version 1)
In Commercial Distribution

  • 00304692416089 ()
DIGI-001

  • Medication reminder application software

Lilly Together - 00300021109554

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers).
ELI LILLY AND COMPANY
MA9131 Android
In Commercial Distribution

  • 00300021109554 ()
MA9131001AM

  • Medication reminder application software

Lilly Together - 00300021107550

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices.
ELI LILLY AND COMPANY
MA7723 IOS
In Commercial Distribution

  • 00300021107550 ()
MA7723001AM

  • Medication reminder application software

BCL-MS - 00199284085701

BeCareLink MS is a mobile medical application designed to assist individuals diagnosed with Multiple Sclerosis (MS) in tracking, assessing, and managing their condition. The application allows users to complete periodic assessments that measure various neurological functions, including cognitive processing, motor coordination, and speech. These assessments are designed to provide longitudinal data regarding disease progression and symptom variability. The app stores user responses and performance data, which can be reviewed by healthcare professionals to aid in clinical decision-making. The software does not provide a diagnosis or treatment recommendation but functions as a patient management and monitoring tool.
BeCare Link, LLC
MS 2.1
In Commercial Distribution

  • 00199284085701 ()
BCL-MS

  • Self-care monitoring/reporting software

LibreLinkUp - 00357599824006

LibreLinkUp
ABBOTT DIABETES CARE INC
72154-01
In Commercial Distribution

  • 00357599824006 ()
72154-01

  • Self-care monitoring/reporting software

Sleep Apnea Notification Feature (SANF) - 00195949116209

Sleep Apnea Notification Feature iOS (version 1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949116209 ()


  • Self-care monitoring/reporting software

Sleep Apnea Notification Feature (SANF) - 00195949116193

Sleep Apnea Notification Feature WatchOS (version 1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949116193 ()


  • Self-care monitoring/reporting software

otoTune app - 00850016231390

APP, Bluetooth, otoTune Android for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990020-SWH
In Commercial Distribution

  • 00850016231390 ()


  • Audiometric/hearing device software

FetaLink - 00850017753129

No Description
Cerner Corporation
FetaLink 200
In Commercial Distribution

  • 00850017753129 ()
10000085

  • Obstetrical monitoring/analysis software

Oracle Health Patient Observer - 00850017753037

No Description
Cerner Corporation
CPO-SP7
In Commercial Distribution

  • 00850017753037 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

DreamMapper - 00606959059801

DreamMapper Mobile iOS China Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059801 ()
1136968

  • Self-care monitoring/reporting software

DreamMapper - 00606959059795

DreamMapper Mobile iOS APAC Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059795 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper - 00606959059788

DreamMapper Mobile iOS EU Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059788 ()
1128264

  • Self-care monitoring/reporting software

DreamMapper - 00606959059771

DreamMapper Mobile iOS NA Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059771 ()
1101478

  • Self-care monitoring/reporting software

DreamMapper - 00606959059764

DreamMapper Mobile Android China Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059764 ()
1136947

  • Self-care monitoring/reporting software

DreamMapper - 00606959059757

DreamMapper Mobile Android APAC Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059757 ()
1127960

  • Self-care monitoring/reporting software

DreamMapper - 00606959059740

DreamMapper Mobile Android EU Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059740 ()
1128265

  • Self-care monitoring/reporting software

DreamMapper - 00606959059733

DreamMapper Mobile Android NA Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059733 ()
1101479

  • Self-care monitoring/reporting software

DreamMapper - 00606959059726

DreamMapper Web China Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059726 ()
1136946

  • Self-care monitoring/reporting software

DreamMapper - 00606959059719

DreamMapper Web APAC Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059719 ()
1127937

  • Self-care monitoring/reporting software

DreamMapper - 00606959059702

DreamMapper Web EU Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059702 ()
1128262

  • Self-care monitoring/reporting software

DreamMapper - 00606959059696

DreamMapper Web NA Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059696 ()
1101679

  • Self-care monitoring/reporting software

DreamMapper - 00606959059078

DreamMapper iOS China Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059078 ()
1136968

  • Self-care monitoring/reporting software

DreamMapper - 00606959059061

DreamMapper iOS APAC Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059061 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper - 00606959059054

DreamMapper iOS EU Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059054 ()
1128264

  • Self-care monitoring/reporting software

DreamMapper - 00606959059047

DreamMapper iOS NA Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059047 ()
1101478

  • Self-care monitoring/reporting software

DreamMapper - 00606959059030

DreamMapper Android China Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059030 ()
1136947

  • Self-care monitoring/reporting software

DreamMapper - 00606959059023

DreamMapper Android APAC Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059023 ()
1127960

  • Self-care monitoring/reporting software

DreamMapper - 00606959059016

DreamMapper Android EU Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059016 ()
1128265

  • Self-care monitoring/reporting software

DreamMapper - 00606959059009

DreamMapper Android NA Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059009 ()
1101479

  • Self-care monitoring/reporting software

DreamMapper - 00606959058996

DreamMapper Web China Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959058996 ()
1136946

  • Self-care monitoring/reporting software

DreamMapper - 00606959058989

DreamMapper Web APAC Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959058989 ()
1127937

  • Self-care monitoring/reporting software

DreamMapper - 00606959058972

DreamMapper Web EU instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959058972 ()
1128262

  • Self-care monitoring/reporting software

DreamMapper - 00606959058965

DreamMapper Web NA instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959058965 ()
1101679

  • Self-care monitoring/reporting software

DreamMapper - 00606959057982

DreamMapper Web (EMEA)
Respironics, Inc.
2.22
In Commercial Distribution

  • 00606959057982 ()
1128262

  • Self-care monitoring/reporting software

DreamMapper - 00606959057722

DreamMapper iOS China Instance
Respironics, Inc.
DreamMapper iOS, China Instance - 2
Not in Commercial Distribution

  • 00606959057722 ()
1136968

  • Self-care monitoring/reporting software

DreamMapper - 00606959057715

DreamMapper App iOS (APAC)
Respironics, Inc.
DreamMapper App iOS, Asia-Pacific Instance - 2
In Commercial Distribution

  • 00606959057715 ()
1127959

  • Self-care monitoring/reporting software
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