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No Description
Hologic, Inc.
I-View Software
In Commercial Distribution
- 15420045512658 ()
SW-03078
- Stationary mammographic x-ray system, digital
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
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
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
No Description
MT MonitorTechnik GmbH & Co. KG
T5
In Commercial Distribution
- 04260497021063 ()
- 04260497021070 ()
- 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
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
Removal Tray Small Lid
Trimed, INC.
RMV-SMALL-LID
In Commercial Distribution
- 00842188126840 ()
RMV-SMALL-LID
- Instrument tray, reusable
Removal Tray Large Lid
Trimed, INC.
RMV-LARGE-LID
In Commercial Distribution
- 00842188126833 ()
RMV-LARGE-LID
- Instrument tray, reusable