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Saw blade 12 x 6 x 0.4mm for MOS
Nouvag AG
5116NOU
In Commercial Distribution
- ENOU5116NOU9 ()
- ENOU5116NOU0 ()
- Surgical saw blade, oscillating, reusable
Saw blade 12 x 4 x 0.4mm for MOS
Nouvag AG
5115NOU
In Commercial Distribution
- ENOU5115NOU9 ()
- ENOU5115NOU0 ()
- Surgical saw blade, oscillating, reusable
Saw blade 12 x 6 x 0.4mm for MOS
Nouvag AG
5114NOU
In Commercial Distribution
- ENOU5114NOU9 ()
- ENOU5114NOU0 ()
- Surgical saw blade, oscillating, reusable
No Description
ALIMED, INC.
9-503
In Commercial Distribution
- 00733657244304 ()
2970017446
- Traction weight
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
CT-356509420
In Commercial Distribution
- 00842430103131 ()
CT-356509420
- Operating table mattress, basic
Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69461
In Commercial Distribution
- 00842430102738 ()
69461
- Wheelchair seat cushion
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques.
Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution
- 00860002545707 ()
- Ultrasound imaging system application software
Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor
Reina Imaging
WDDR[X]
In Commercial Distribution
- 00860001700176 ()
- Footstool
- Flat panel x-ray detector/film cassette weight-bearing protector
SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions of the body, or increase image sharpness for head MRI.
Subtle Medical, Inc.
2.x
In Commercial Distribution
- 00860000171212 ()
- Radiology DICOM image processing application software
SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images (including PET/CT and PET/MRI).
Subtle Medical, Inc.
2.x
In Commercial Distribution
- 00860000171205 ()
- Radiology DICOM image processing application software
Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.
PAIGE.AI, INC.
1.X
In Commercial Distribution
- 00860007599118 ()
- Histology/cytology/microbiology image-analysis interpretive software IVD
FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus renders the uploaded slide images and is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis.
PAIGE.AI, INC.
2.X
In Commercial Distribution
- 00860007599101 ()
- Pathology information system
No Description
Aiq Global, Inc.
2.x
In Commercial Distribution
- 00860007104916 ()
- Radiological PACS software
SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
RADIALOGICA LLC
1.x
In Commercial Distribution
- 00863284000315 ()
- Radiation therapy software
A fully-integrated data display, communication and analysis software platform that enables users to access, analyze and share diagnostic images and radiotherapy treatment plans.
RADIALOGICA LLC
1.x
In Commercial Distribution
- 00863284000308 ()
- Radiology DICOM image processing application software
No Description
SCIMAGE, INC
3.x
In Commercial Distribution
- 00861917000305 ()
- Radiological PACS software
Steth IO - The Smartphone Stethoscope for iPhone X
Steth IO
iPhone X
In Commercial Distribution
- 00860135001934 ()
- Electronic acoustic stethoscope
No Description
Whoop, Inc.
1.x
In Commercial Distribution
- 00860012964819 ()
- Electrocardiograph, home-use
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.3.x
- Vulnerable patient home-monitoring software, professional-only
Nitrile Examination Gloves
TEC GLOVES USA, LLC
X Large
In Commercial Distribution
- 00860009233577 ()
- 00860009233539 ()
TC21NXL
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Garmin International, Inc.
1.x
In Commercial Distribution
- 00860009117716 ()
- Cardiopulmonary physiological parameter analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution
- 00860009117709 ()
- Cardiopulmonary physiological parameter analysis 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
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
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 learning 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.
1.7.X
In Commercial Distribution
- 00628011382177 ()
- Radiation therapy software
No Description
BONRAYBIO CO., LTD.
X QC
In Commercial Distribution
- 04719874740733 ()
- Sperm concentration indicator IVD, control
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
No Description
SYSMEX CORPORATION
1.X
In Commercial Distribution
- 04987562488506 ()
AB364503
- Clinical laboratory information system
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
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) 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 (L VO) in head CTA images.
StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow.
Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
3.x
In Commercial Distribution
- 00882916000530 ()
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
1.x
In Commercial Distribution
- 00882916000516 ()
v1.x and v2.0
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
6.x
In Commercial Distribution
- 00882916000028 ()
- MRI system application software
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
5.x
In Commercial Distribution
- 00882916000011 ()
- MRI system application software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
88.1.x
Not in Commercial Distribution
- 05902729753500 ()
- CAD/CAM software
Ortho System is a software system intended for use as a medical front-end for orthodontic clinics and laboratories. It supports orthodontic diagnosis, treatment planning and follow-up, CAD modelling of orthodontic appliances and indirect bonding as well as archiving of case information.
3shape A/S
85.x
In Commercial Distribution
- 05902729753487 ()
- Dental treatment application software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
88.2.x
In Commercial Distribution
- 05902729753630 ()
- CAD/CAM software