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No Description
Changzhou Sifary Medical Technology Co., Ltd.
Ultra X
In Commercial Distribution
- 06972597781171 ()
- Ultrasonic dental scaling/debridement system
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
No Description
H & O Equipments SA
CryoProbe X+
In Commercial Distribution
- 15407008481114 ()
S-HO-CXPRP-02
- General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
CryoProbe X+
In Commercial Distribution
- 15407008481107 ()
S-HO-CXPRP-01
- General cryosurgical system, cryogen gas, mechanical
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
NEOLUX X 350-48
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution
- B280864NL4800X0 ()
864NL4800X
- Ultraviolet phototherapy unit, professional
NEOLUX X 350-40
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution
- B280864NL4000X0 ()
864NL4000X
- Ultraviolet phototherapy unit, professional
NEOLUX X 311/350-24/24
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution
- B280864NL2424X0 ()
864NL2424X
- Ultraviolet phototherapy unit, professional
NEOLUX X 311/350-20/20
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution
- B280864NL2020X0 ()
864NL2020X
- Ultraviolet phototherapy unit, professional