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suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.3
Not in Commercial Distribution
- 00864747000255 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.2
Not in Commercial Distribution
- 00864747000248 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.1
Not in Commercial Distribution
- 00864747000224 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.0
Not in Commercial Distribution
- 00864747000217 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
3.0.1
Not in Commercial Distribution
- 00864747000200 ()
- MRI system application software
Software, CyberKnife Version 11.1 (Software group that operates CyberKnife Treatment Delivery System)
ACCURAY INCORPORATED
1061945
In Commercial Distribution
- 00811376030023 ()
NA
- Linear accelerator system
IQ HOLTER PLUG-IN SOFTWARE v10.0.6: New Software Release for Midmark Digital Holter.
MIDMARK CORPORATION
P/N 4-100-3140
In Commercial Distribution
- 00841709118067 ()
- Electrocardiographic long-term ambulatory recording analyser
Software, Version 11.0, CyberKnife
(Operating Software group for CyberKnife Treatment Delivery System)
ACCURAY INCORPORATED
1055810
In Commercial Distribution
- M6581055810 ()
NA
- Linear accelerator system
Norav 1200 Series PC-ECG Software Kit with the following Option(s):
- S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer)
- S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools
- I2 = Resting-ECG Measurement and Advanced Interpretation
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I2
In Commercial Distribution
- 07290110255022 ()
HASP-SW-K-S2I2-01
- Patient-administration information system application software
- Cardiovascular risk evaluation interpretive software
- Cardiopulmonary stress exercise monitoring system computer
Norav 1200 Series PC-ECG Software Kit for COSMED with the following Option(s):
- S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer)
- S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools
- I1 = Restin-ECG Measurement
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1
In Commercial Distribution
- 07290110252793 ()
HASP-SW-K-S2I1-01
- Cardiovascular risk evaluation interpretive software
- Cardiopulmonary stress exercise monitoring system computer
No Description
Thought Technology Ltd.
SA7900AR
In Commercial Distribution
- 07540191000647 ()
- Biofeedback system application software
Ultrasound-guided radio-frequency ablation system software
Gynesonics, Inc.
SW-001
Not in Commercial Distribution
- 10817929020357 ()
SW-001
- Ultrasound-guided radio-frequency ablation system software
No Description
NFANT LABS LLC
1
In Commercial Distribution
- 00861410000246 ()
NA4
- Biofeedback system application software
No Description
NFANT LABS LLC
1
In Commercial Distribution
- 00861410000208 ()
ND3
- Biofeedback system application software
9250-ST Telesis® ST Software for Speech Therapy MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250-ST
In Commercial Distribution
- 00852423006431 ()
9250-ST
- Biofeedback system application software
Synergy® 3-Dimensional Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9225
In Commercial Distribution
- 00852423006103 ()
9225
- Biofeedback system application software
Primus® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9275
In Commercial Distribution
- 00852423006097 ()
9275
- Biofeedback system application software
Telesis® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250
In Commercial Distribution
- 00852423006080 ()
9250
- Biofeedback system application software
NKPW Psychophysiological biofeedback system A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.
HJLM Biofeedback system application software An application software program designed for use in, or together with, a biofeedback system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
Ochs Labs LLC
LW3
In Commercial Distribution
- G253LW30 ()
- Biofeedback system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_UI
In Commercial Distribution
- 07290019352037 ()
- Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Seamless
In Commercial Distribution
- 07290019352020 ()
- Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Mobile
In Commercial Distribution
- 07290019352013 ()
- Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Platform
In Commercial Distribution
- 07290019352006 ()
- Ultrasound imaging system application software
BriefCase-Quantification is an Automated Radiological Image Processing Software.
AIDOC MEDICAL LTD
BC.QTF.5.y.z
In Commercial Distribution
- 07290018052280 ()
- Radiology DICOM image processing application software
BriefCase-Quantification is an Automated Radiological Image Processing Software.
AIDOC MEDICAL LTD
BC.QTF.4.x.y
In Commercial Distribution
- 07290018052266 ()
- Radiology DICOM image processing application software
BriefCase-Quantification is an Automated Radiological Image Processing Software.
AIDOC MEDICAL LTD
BC.QTF.3.x.y
In Commercial Distribution
- 07290018052235 ()
- Radiology DICOM image processing application software
No Description
STRYKER CORPORATION
01030300
In Commercial Distribution
- 07613327459081 ()
0103-0300
- Radiology DICOM image processing application software
No Description
Chengdu Wision Medical Device Co., Ltd.
WIPD01
In Commercial Distribution
- 06973770840012 ()
- Endoscopic video image interpretive software
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias.
The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is
intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
FITBIT, INC.
FB603
In Commercial Distribution
- 00810038851983 ()
- Cardiopulmonary physiological parameter analysis software
No Description
STRYKER CORPORATION
3105001000
In Commercial Distribution
- 07613327382570 ()
3105001000
- Radiology DICOM image processing application software
Burn Navigator RX
ARCOS, INC.
RX
In Commercial Distribution
- B2551143 ()
1143
- Clinical information system web-based application software
Burn Navigator H2 Transport
ARCOS, INC.
H2 Transport
In Commercial Distribution
- B2551125 ()
1125
- Clinical information system web-based application software
Burn Navigator H2 model
ARCOS, INC.
H2
In Commercial Distribution
- B2551120 ()
1120
- Clinical information system web-based application software
Viz ICH+ v1.3 (2025-04-06)
VIZ.AI, INC.
Viz ICH+ Software
In Commercial Distribution
- 00811852030349 ()
- Radiology DICOM image processing application software
Viz HCM v1.1 (2024-06-19)
VIZ.AI, INC.
Viz HCM Software
In Commercial Distribution
- 00811852030332 ()
- Cardiopulmonary physiological parameter analysis software
Viz RV/LV v1.2 (2023-04-19)
VIZ.AI, INC.
Viz RV/LV Software
In Commercial Distribution
- 00811852030295 ()
- Radiology DICOM image processing application software
This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.
FUJIFILM CORPORATION
EW10-EC02
In Commercial Distribution
- 04547410541199 ()
- Endoscopic video image interpretive software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA3
In Commercial Distribution
- 04068151027013 ()
- PET system application software
- SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589501
In Commercial Distribution
- 04068151009477 ()
- PET system application software
- SPECT system application software
No Description
Visage Imaging GmbH
1.0
In Commercial Distribution
- 04251332930008 ()
- Radiological PACS software
No Description
Siemens Healthcare GmbH
VA3
In Commercial Distribution
- 04056869985947 ()
- Radiology DICOM image processing application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431591
In Commercial Distribution
- 04056869975559 ()
- PET system application software
- SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431590
In Commercial Distribution
- 04056869975535 ()
- SPECT system application software
- PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431567
In Commercial Distribution
- 04056869975528 ()
- SPECT system application software
- PET system application software
No Description
Siemens Healthcare GmbH
11665399
In Commercial Distribution
- 04056869968278 ()
- Radiology DICOM image processing application software
No Description
Siemens Healthcare GmbH
11582982
In Commercial Distribution
- 04056869298207 ()
- Radiology DICOM image processing application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431553
In Commercial Distribution
- 04056869279800 ()
- SPECT system application software
- PET system application software
AI-Rad Companion Prostate MR About Box
Siemens Healthcare GmbH
11545289
In Commercial Distribution
- 04056869274638 ()
- Radiology DICOM image processing application software
AI-Rad Companion Prostate MR About Box
Siemens Healthcare GmbH
11294432
Not in Commercial Distribution
- 04056869257952 ()
- Radiology DICOM image processing application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA2
In Commercial Distribution
- 04056869952574 ()
- PET system application software
- SPECT system application software