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Blackford Platform v2.0.x, supplied with Blackford Registration Application (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.0.x
In Commercial Distribution
- 05060570830006 ()
- Radiological PACS 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
Samsung Health Body Composition tracker for android OS smart watch
Samsung Electronics Co., Ltd.
1.x
Not in Commercial Distribution
- 08806092938854 ()
- Bioelectrical body composition analyser
Samsung Health Body Composition tracker for android OS smart phone
Samsung Electronics Co., Ltd.
1.x
Not in Commercial Distribution
- 08806092938847 ()
- Bioelectrical body composition analyser
No Description
SYRMA JOHARI MEDTECH LIMITED
X Trainer
In Commercial Distribution
- 08908008085055 ()
- Physical therapy transcutaneous electrical stimulation system, line-powered
No Description
SYRMA JOHARI MEDTECH LIMITED
X FORCE
In Commercial Distribution
- 08908008085048 ()
- Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
BONRAYBIO CO., LTD.
X QC
In Commercial Distribution
- 04719874740733 ()
- Sperm concentration indicator IVD, control
No Description
SYSMEX CORPORATION
1.X
In Commercial Distribution
- 04987562488506 ()
AB364503
- Clinical laboratory information system
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine leaming models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system file system (importing DICOM image.dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.8.X
In Commercial Distribution
- 00628011382184 ()
- Radiation therapy software