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StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.
Circle Neurovascular Imaging Inc
v1.x
In Commercial Distribution
- B926SSSX10 ()
- CT system application software
No Description
MILVUE
V1.1.x
In Commercial Distribution
- 03770024774047 ()
- Radiological PACS software
No Description
GLEAMER
1.0.X
In Commercial Distribution
- 03770020839108 ()
- Radiological PACS software
No Description
GLEAMER
1.0.X
In Commercial Distribution
- 03770020839092 ()
- Radiological PACS software
No Description
GLEAMER
1.1.X
In Commercial Distribution
- 03770020839085 ()
- Radiological PACS software
No Description
QYNAPSE
1.X
In Commercial Distribution
- 03770016198004 ()
- Radiology DICOM image processing application software
A lightweight folding wheelchair that provides mobility and portability for those Adults that weigh 140 kilograms (309 lbs.) or less.
SUNRISE MEDICAL (US) LLC
QS5 X
In Commercial Distribution
- 00016958059526 ()
EIF7
- Push-rim manual wheelchair, non-bariatric
Rapid Platform plus cleared indications for Rapid version 6.x
Ischemaview, Inc.
6.x
In Commercial Distribution
- B761R60 ()
- Radiological PACS software
Calculation Services 1.X
CAREFUSION 303, INC.
1.X
In Commercial Distribution
- 10885403510489 ()
- Infusion pump medication-dosage application software
Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution
- 09351356000055 ()
- Phonocardiograph
- Stethoscope application software
Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution
- 09351356000048 ()
- Phonocardiograph
- Stethoscope application software
Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System.
The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution
- 09351356000031 ()
- Phonocardiograph
- Stethoscope application software
Non-powdered patient examination gloves
C&A Marketing, Inc.
X Large
In Commercial Distribution
- 00843812168458 ()
- 10843812168455 ()
WVEBNGXL
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information.
The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.
MeVis BreastCare GmbH & Co. KG
1.1.x
In Commercial Distribution
- 04262459510028 ()
- Diagnostic x-ray digital imaging system workstation application software
MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information.
The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.
MeVis BreastCare GmbH & Co. KG
1.0.x
Not in Commercial Distribution
- 04262459510011 ()
- Diagnostic x-ray digital imaging system workstation application software
NeuroStar Mobile Console, recertified
NEURONETICS, INC.
3.X
In Commercial Distribution
- 00850005944430 ()
81-02315-00R
- Magnetic neural stimulation system
NeuroStar Mobile Console, recertified
NEURONETICS, INC.
2.X
In Commercial Distribution
- 00850005944423 ()
81-01315-00R
- Magnetic neural stimulation system
No Description
PHILIPS FRANCE COMMERCIAL
2.4.x
In Commercial Distribution
- G637CEA0 ()
- Cardiopulmonary physiological parameter analysis software
300W xenon light source with backup LED
ILO electronic GmbH
X 300AT-LED
In Commercial Distribution
- 04250369707737 ()
818-1028
- Endoscopic light source unit, line-powered
300W xenon light source with backup LED
ILO electronic GmbH
X 300M-LED
In Commercial Distribution
- 04250369707713 ()
818-1023
- Endoscopic light source unit, line-powered