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Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems.
The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution
- 00884838107557 ()
839060
- Radiological PACS software
- Radiology picture archiving and communication system workstation
CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure.
The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas).
CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope.
The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement.
ODIN MEDICAL LIMITED
v1.4.x
In Commercial Distribution
- 15065010840024 ()
- Endoscopic video image interpretive software
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094936889 ()
- Patient general health self-management software
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094936872 ()
- Patient general health self-management software
No Description
Bausch & Lomb GmbH
E3839 X
In Commercial Distribution
- 04058935011659 ()
- Suturing needle holder, reusable
No Description
Budget Hearing Aids, LLC
Atom X
In Commercial Distribution
- 00850065060880 ()
- Air-conduction hearing aid, canal
No Description
Bausch & Lomb GmbH
E3305 X
In Commercial Distribution
- 04058935012045 ()
- Corneal scissors, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
VTX2020
In Commercial Distribution
- 00856817005291 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
VTX2000
In Commercial Distribution
- 00856817005284 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
VTX5050
In Commercial Distribution
- 00856817005277 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable