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MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of:
(1) MR Diffusion-weighted imaging (DWI)
(2) MR FLAIR images.
The device is intended to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians in the imaging assessment workflow:
• computation of the map relative to the water diffusion, i.e., ADC map;
• extraction and communication of metrics derived from the above map, i.e., hypointense area on ADC, and FLAIR series as well as ratios with contralateral information on FLAIR images.
The results of MR DWI/FLAIR Measurement V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained professionals are responsible for viewing the full set of native images per the standard of care.
MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms.
Olea Medical USA
V1.0
In Commercial Distribution
- EOLEMRDFMV1P00 ()
- Radiological PACS software
Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers.
Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps.
Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis.
Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images.
Olea Medical USA
V1.0
In Commercial Distribution
- EOLEFMRIV1P00 ()
- Radiological PACS software
CT Perfusion V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from CT Perfusion data and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided.
The device is intended to be used by trained professionals with medical imaging education including but not limited to, physicians and medical technicians in the imaging assessment workflow by extraction and communication of metrics from CT Perfusion dataset.
The results of CT Perfusion V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained professionals are responsible for viewing the full set of native images per the standard of care.
CT Perfusion V1.0 can be integrated and deployed through technical platforms.
Olea Medical USA
V1.0
In Commercial Distribution
- EOLECTPERFUSIONV1P00 ()
- Radiological PACS software
breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package cleared under K152602. It is intended to be used by trained breast imaging physicians and trained MRI technologists.
breastscape V1.0 includes 2 software modules :
- BreastApp supports the visualization, analysis, and reporting of lesions measurements and analysis.
- BreastLoc to assist users in planning MR guided breast interventional procedures.
Data and images are acquired through DICOM compliant imaging devices and modalities.
Olea Medical USA
V1.0
In Commercial Distribution
- EOLEBREASTSCAPEV1P00 ()
- Radiological PACS software
Oral-B Nighttime Dental Guard - For Nighttime Teeth Grinding Protection -
Oralabs, LLC
1
In Commercial Distribution
- D132MG0010 ()
- 00728947000210 ()
- 1 dental guard to mold
- Mouthguard, reusable
Angled Electrode Extender, 6cm Length
UTAH MEDICAL PRODUCTS, INC.
Smalll Electrode Extender
In Commercial Distribution
- H671DXTS062 ()
- H671DXTS061 ()
- H671DXTS060 ()
- Length: 6 Centimeter
DXT-S06
- Open-surgery electrosurgical electrode, monopolar, single-use
Angled Electrode Extender, 9cm Length
UTAH MEDICAL PRODUCTS, INC.
Large Electrode Extender
In Commercial Distribution
- H671DXTL092 ()
- H671DXTL091 ()
- H671DXTL090 ()
- Length: 9 Centimeter
DXT-L09
- Open-surgery electrosurgical electrode, monopolar, single-use
Disposable Electrosurgical Electrode, 8cm Long Straight Tip with Retracted Insulation
UTAH MEDICAL PRODUCTS, INC.
Needle Electrode, 8cm
In Commercial Distribution
- H671DN08102 ()
- H671DN08101 ()
- H671DN08100 ()
- Length: 8 Centimeter
DN-0810
- Open-surgery electrosurgical electrode, monopolar, single-use
Disposable Electrosurgical Electrode, 8cm Long Straight Tip
UTAH MEDICAL PRODUCTS, INC.
Needle Electrode, 8cm
In Commercial Distribution
- H671DN08002 ()
- H671DN08001 ()
- H671DN08000 ()
- Length: 8 Centimeter
DN-0800
- Open-surgery electrosurgical electrode, monopolar, single-use
Disposable Electrosurgical Electrode, 4cm Long with 10mm Long 45 Degree Tip
UTAH MEDICAL PRODUCTS, INC.
Needle Electrode, 4cm
In Commercial Distribution
- H671DN04452 ()
- H671DN04451 ()
- H671DN04450 ()
- 45 Degree, 10 mm Tip
- Length: 4 Centimeter
DN-0445
- Open-surgery electrosurgical electrode, monopolar, single-use