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DYMAXEON OPEN MONOAXIAL PEDICULAR SCREW Ø5.5 x50mm (BLUE)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution
- 00815500020157 ()
- 10815500020154 ()
- Length: 50 Millimeter
06.2350B
- Bone-screw internal spinal fixation system, sterile
DYMAXEON OPEN MONOAXIAL PEDICULAR SCREW Ø5.5 x45mm (BLUE)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution
- 00815500020140 ()
- 10815500020147 ()
- Length: 45 Millimeter
06.2345B
- Bone-screw internal spinal fixation system, sterile
DYMAXEON OPEN MONOAXIAL PEDICULAR SCREW Ø5.5 x40mm (BLUE)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution
- 00815500020133 ()
- 10815500020130 ()
- Length: 40 Millimeter
06.2340B
- Bone-screw internal spinal fixation system, sterile
DYMAXEON OPEN MONOAXIAL PEDICULAR SCREW Ø5 x70mm (YELLOW)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution
- 00815500020119 ()
- 10815500020116 ()
- Length: 70 Millimeter
06.2270B
- Bone-screw internal spinal fixation system, sterile
nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pipelines, which are executed automatically when image data is received or manually by a user. The user can choose to send the results to other DICOM nodes for review or use nordicView for their review and export the results to PACS, neuro navigation systems, or other DICOM-compliant modalities.
nordicMEDiVA is a server-client solution and can be installed on a local server at the customer's location or in a cloud-based setup. The software is containerized with Docker technology and operates on a GPU-enabled Linux host. This allows customers to manage the server environment themselves or use it as a Software as a Service (SaaS) hosted by NordicImagingLab AS in the cloud. Customers can install the server on physical hardware, virtual machines, or in their own cloud infrastructure.
The device comprises a database, DICOM functionality, various APIs, a visualization engine, and medical image analysis modules. The device is not intended for long-term persistent storage of medical diagnostic data.
The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks.
The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.
Nordicneurolab AS
2
In Commercial Distribution
- 07090042059077 ()
- MRI system application software
External support for vascular access arteriovenous fistulas
LAMINATE MEDICAL TECHNOLOGIES LTD
2
In Commercial Distribution
- 07290016063325 ()
FG0032
- Arteriovenous fistula extraluminal mesh-sleeve
Sleep disorder interpretive software, professional-only
OXEHEALTH LIMITED
2
In Commercial Distribution
- 50607514500023 ()
- Sleep disorder interpretive software, professional-only
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And Respiratory Rate
OXEHEALTH LIMITED
2
In Commercial Distribution
- 50607514500009 ()
- Near-infrared camera vital sign measurement software
MRI Planner is a stand alone software product intended to enable a completely MRI only workflow in
radiotherapy planning. The MRI Planner software achieves this by analyzing a dedicated MR
image and generating a synthetic CT image that can replace the conventional CT in the treatment
planning process. In addition, the software also performs automated contouring of risk organs in
certain anatomies. In the current version of MRI Planner, synthetic CT generation is supported for
the brain, head-neck and pelvis anatomies, whereas automated risk organ contouring is
supported for bladder, colon and femoral heads for prostate cancer patients only.
Spectronic Medical AB
2
In Commercial Distribution
- 07350097430017 ()
- Radiation therapy software
The Sectra Calibration Unit consists of calibration holders and markers.
The calibration holders are intended to correctly place the calibration markers in relation to the patient during image acquisition.
The calibration markers will be visible on the x-ray images and are intended to serve as scaling references.
Typical users of the device are trained professionals, for example radiology technicians.
Sectra AB
2
In Commercial Distribution
- 07350092810395 ()
- General-purpose diagnostic x-ray phantom, test object
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