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SiteRite 9 Sherlock Software v3.3.1
Bard Access Systems, Inc.
Sherlockv3.3.1
In Commercial Distribution
- 00801741219221 ()
Sherlockv3.3.1
- Central venous catheter navigation system, electrocardiographic/magnetic
- General-purpose ultrasound imaging system
DYONICS PULSE SOFTWARE TOP LEVEL
Smith & Nephew, Inc.
72204606
Not in Commercial Distribution
- 00885554037616 ()
72204606
- Multidisciplinary medical image management software
PCMCIA CARD SOFTWARE V3.71 SPANISH
Smith & Nephew, Inc.
72201923
In Commercial Distribution
- 00885554015829 ()
72201923
- Percutaneous radio-frequency ablation system generator
DYONICS 25 SOFTWARE UPGRADE V1.4
Smith & Nephew, Inc.
72200875
Not in Commercial Distribution
- 00885554013597 ()
72200875
- Robotic surgical navigation system application software
PET/CT Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MI
In Commercial Distribution
- 06971576834037 ()
- Radiology DICOM image processing application software
PRODUCT SOFTWARE MMT-7350 PROWEB 3.13A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution
- 00763000424138 ()
- Patient health record information system application software
SOFTWARE 9733763 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733763
In Commercial Distribution
- 00763000253158 ()
- Multi-purpose stereotactic surgery system
Transducer Array Layout Planning software
Novocure GmbH
1.1.0
In Commercial Distribution
- 07290107983136 ()
SW000060
- Alternating electric field antimitotic cancer treatment system generator
Medoc Main Station Base Software
MEDOC LTD.
MMS
In Commercial Distribution
- 07290103039011 ()
SW 00012
- Thermotester, diagnostic
PillCam Software v9.0 WW WS
Given Imaging, Inc.
FGS-0626
In Commercial Distribution
- 07290101369530 ()
- Video capsule endoscopy system application software
AR v3.0 Software Upgrade kit
Given Imaging, Inc.
FGS-8031
In Commercial Distribution
- 07290101369059 ()
- Manometric gastrointestinal motility analysis system
PillCam Software Upgrade v9 , USA
Given Imaging, Inc.
FGS-0613
In Commercial Distribution
- 07290101366768 ()
- Video capsule endoscopy system application software
Kaluza C Flow Cytometry Software
Beckman Coulter, Inc.
Flow Cytometry Software
In Commercial Distribution
- 15099590705169 ()
C21166
- Laboratory instrument/analyser application software IVD
moorFLPI-2 Clinical PC Software V1
MOOR INSTRUMENTS LIMITED
1
Not in Commercial Distribution
- 15060484490157 ()
- Cutaneous microcirculation laser Doppler imaging device
moorFLPI2- Measurement PC Software V2
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution
- 15060484490126 ()
- Cutaneous microcirculation laser Doppler imaging device
moorFLPI-2 Review PC Software V5
MOOR INSTRUMENTS LIMITED
5
In Commercial Distribution
- 15060484490119 ()
- Cutaneous microcirculation laser Doppler imaging device
PRODUCT SOFTWARE MMT-7350 PROWEB 4.1A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution
- 00763000984762 ()
- Patient health record information system application software
m2000rt SYSTEM SOFTWARE Release 8.0
ABBOTT MOLECULAR INC.
08N89-001
In Commercial Distribution
- 00884999043503 ()
08N89-001
- Laboratory analyser operation system software IVD
m2000sp SYSTEM SOFTWARE, Release 8.0
ABBOTT MOLECULAR INC.
08N88-001
In Commercial Distribution
- 00884999043497 ()
08N88-001
- Laboratory instrument/analyser application software IVD
2-channel (4 electrodes)
Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
MT MonitorTechnik GmbH & Co. KG
PKM4
In Commercial Distribution
- 04260497025016 ()
- Electroencephalographic monitoring system
1-channel (3 electrodes)
Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
MT MonitorTechnik GmbH & Co. KG
PKM1
In Commercial Distribution
- 04260497025009 ()
- Electroencephalographic monitoring system
No Description
MT MonitorTechnik GmbH & Co. KG
T5
In Commercial Distribution
- 04260497021063 ()
- 04260497021070 ()
- Electroencephalographic monitoring system
cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution
- EBCI80600 ()
- Electroencephalographic spectrum analyser
Rapid System Update
Ischemaview, Inc.
5.101
In Commercial Distribution
- B761R51011 ()
- Radiological PACS software
The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Samsung Electronics Co., Ltd.
1.3
In Commercial Distribution
- 08806094948240 ()
- Self-care monitoring/reporting software
The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Samsung Electronics Co., Ltd.
1.3
In Commercial Distribution
- 08806094948233 ()
- Self-care monitoring/reporting software
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094940763 ()
- Self-care monitoring/reporting software
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094940756 ()
- Self-care monitoring/reporting software
StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300).
CARDIAC INSIGHT, INC.
C300/D300
Not in Commercial Distribution
- 00857553006092 ()
- 00857553006061 ()
C300/D300
- Electrocardiographic ambulatory recorder
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
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
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
Thought Technology Ltd.
SA7900AR
In Commercial Distribution
- 07540191000647 ()
- Biofeedback system application software
Software, Version 1.0.0.4, Treatment Delivery Console, Radixact
(Operating Software for Radixact Treatment Delivery System)
ACCURAY INCORPORATED
1057727
In Commercial Distribution
- M65810577270 ()
NA
- Linear accelerator system
VITEK®2 software 9.01.0, advanced software to run your VITEK®2 system
BIOMERIEUX , INC.
9.01.0
Not in Commercial Distribution
- 03573026555504 ()
- Microorganism identification/antimicrobial-susceptibility analyser IVD
360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation.
KICO KNEE INNOVATION COMPANY PTY LIMITED
2.2.0
In Commercial Distribution
- B432360CAS2200 ()
- Robotic surgical navigation system application software