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Software for cardiac image analysis.
Medviso AB
2
In Commercial Distribution
- 07350010100027 ()
- MRI system application software
Software for medical image analysis.
Medviso AB
2
In Commercial Distribution
- 07350010100010 ()
- Radiology DICOM image processing application software
The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System
analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during
sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders,
where it may inform or drive clinical management for children, adolescents and adults.
The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare
professionals in diagnosis and management of sleep disordered breathing.
The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified
healthcare professional.
MYCARDIO LLC
2
In Commercial Distribution
- B315SLEEPIMAGESYSTEMD8 ()
- Sleep disorder interpretive software, professional-only
BTS G-SENSOR 2 is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tri-axial gyroscope, that worn by the patient allows a functional gait analysis.
BTS SPA
2
In Commercial Distribution
- B179GSN2 ()
- B179GSN21 ()
BTSGSN2
- Gait analysis system
No Description
Gulden Ophthalmics Inc.
2
In Commercial Distribution
- B091230120 ()
- B091230122 ()
23012
- Corneal shield applicator
ENDODRAPE® Colonoscopy w/o ScopeGuard, 49"x 52"
VORTEK SURGICAL, LLC
2
In Commercial Distribution
- B27820689076068857 ()
- B27810689076068857 ()
68857
- Patient surgical drape, single-use, non-sterile
No Description
MATH RESOLUTIONS, LLC
2
In Commercial Distribution
- B229RTDP21 ()
- Radiation therapy software
No Description
MATH RESOLUTIONS, LLC
2
In Commercial Distribution
- B229MRT21 ()
- Radiation therapy software
Cutaneous Electrode Garment
AXIOBIONICS
2
In Commercial Distribution
- B3670320 ()
03
- Transcutaneous electrical stimulation electrode, single-use
Cutaneous Electrode Pair 4" x 6"
AXIOBIONICS
2
In Commercial Distribution
- B367136P20 ()
136P
- Transcutaneous electrical stimulation electrode, single-use