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Image-Line Notched Medial Retr Blade, 23 x 30mm, silver New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6160H
In Commercial Distribution
- 00888515190702 ()
73-6160H
- Surgical retractor/retraction system blade, reusable
New Orleans needle holder, 7'', straight, serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
New Orleans needle holder
In Commercial Distribution
- 00190660119843 ()
53-115
- Suturing needle holder, reusable
New handle, Alligator, with spike, PE coated, Two Wire, 2.2*1800 mm
Micro-Tech (Nanjing) Co., Ltd.
SCNBF13-10122180
In Commercial Distribution
- 56932503540648 ()
- 46932503540641 ()
- 66932503540645 ()
- 76932503540642 ()
- Lumen/Inner Diameter: 2.8 Millimeter
- Length: 180 Centimeter
- Flexible endoscopic biopsy forceps, single-use
Reusable SpO2 Sensor/Nellcor/ New Adjustable Hinge Finger Clip/Adult/1.1M/DB9M
Unimed Medical Supplies, Inc.
U403NC-01XP
In Commercial Distribution
- 06945664828697 ()
- Pulse oximeter probe, reusable
Reusable SpO2 Sensor/Nellcor/ New Finger Clip/Adult/Scilicone Shield/1.1M/DB9M
Unimed Medical Supplies, Inc.
U403L-01XP
In Commercial Distribution
- 06945664828666 ()
- Pulse oximeter probe, reusable
Reusable SpO2 Sensor/CSI/Ear clip/Adult/3.0M/New DB9M Right Angle
Unimed Medical Supplies, Inc.
U910-75N
In Commercial Distribution
- 06945664825405 ()
- Pulse oximeter probe, reusable
Reusable SpO2 Sensor/CSI/Finger Clip/Adult/3.0M/New DB9M Right Angle
Unimed Medical Supplies, Inc.
U410-75N
In Commercial Distribution
- 06945664825153 ()
- Pulse oximeter probe, reusable
Reusable SpO2 Sensor/CSI/Soft Tip/Adult/3.0M/New DB9M Right Angle
Unimed Medical Supplies, Inc.
U410S-75N
In Commercial Distribution
- 06945664822763 ()
- Pulse oximeter probe, reusable
Repetitive blood oxygen probe/Nellcor-oximax/finger clip/adult / 1.1m /103X/NEW Partssource
Unimed Medical Supplies, Inc.
U403-01P(NPS)
In Commercial Distribution
- 06945664859684 ()
- Pulse oximeter probe, reusable
NIBP blood pressure connection/single tube/infant + newborn/BP16-BP56/2.5m /NEW Partssource
Unimed Medical Supplies, Inc.
HSN-16-56
In Commercial Distribution
- 06945664877299 ()
- Blood pressure cuff, reusable
DENTAL IMPLANT ABUTMENT NEW Plastic Abutment for 3D with collar LAB Impression
Ritter Implants GmbH & Co. KG
3DSPA-8C
In Commercial Distribution
- ERIT3DSPA8C1 ()
- Screw endosteal dental implant, two-piece
NEW Burn Stop 8"x8" dressing 50/case (REF BSD400R); BD Gel
WATER-JEL TECHNOLOGIES, L.L.C.
BSD400.02.000
In Commercial Distribution
- 00743537000623 ()
- 00743537000357 ()
BSD400.02.000
- Synthetic polymer burn dressing, gel-coated
OMX52P Split Horizontal Corded Foam Grounding Plate- New Oversized Gel -Single Pack
MEDIMAX TECH INC.
OMX52P ESU Plate
In Commercial Distribution
- 20817325022907 ()
- 10817325022900 ()
- 00817325022903 ()
- Electrosurgical return electrode, single-use
Klarity Customized Head Mold 15x31cm with New Neck Flare and 6cm bump
Klarity Medical Products, LLC
R550-PS45
In Commercial Distribution
- 00817355027961 ()
- Patient positioning foam mould kit
LECRON Carver Dental Wax Amalgam Spatula Stainless Steel Lab Pro New Instruments
Wise Linkers, LLC
242557
In Commercial Distribution
- D1272425571 ()
1
- Dental restoration carver, amalgam, reusable
Localization and characterization of thyroid ultrasound images.
SEE-MODE TECHNOLOGIES PTE. LTD.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
In Commercial Distribution
- 00860006305727 ()
- Ultrasound imaging system application software
Analysis and reporting of vascular ultrasound images
SEE-MODE TECHNOLOGIES PTE. LTD.
AVA (Augmented Vascular Analysis)
In Commercial Distribution
- 00860006305703 ()
- Ultrasound imaging system application software
MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution
- 00860006066307 ()
- Ultrasound imaging system application software
Framewise Integrated Real-Time MRI Monitoring
Turing Medical Technologies Inc
v5
In Commercial Distribution
- 00860004785101 ()
- Length: 155 Millimeter
- Width: 65 Millimeter
- Height: 206 Millimeter
FIRMM®
- MRI system application software
No Description
CAPTION HEALTH, INC.
Alastor
In Commercial Distribution
- 00860003586341 ()
- Ultrasound imaging system application software
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
CAPTION HEALTH, INC.
Apollo
In Commercial Distribution
- 00860003586334 ()
511-00021
- Ultrasound imaging system application software
Caption AI (Caption Guidance + Caption Interpretation) on portable handheld ultrasound.
The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation.
The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
Adonis
511-00019
- Ultrasound imaging system application software
The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation.
The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
0.10, 0.11, 1.1, 1.2, 1.3, 1.4
Not in Commercial Distribution
- 00860003586303 ()
511-00003
- Ultrasound imaging system application software
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
No Description
CORTECHS LABS INC
NQ BT
In Commercial Distribution
- 00860000004824 ()
- MRI system application software
Vascular Flow Analysis System
VASSOL, INC.
VS5060
In Commercial Distribution
- 00867170000106 ()
- MRI system application software
STAGE is a MR post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE runs within a VM environment on hardware that meets the minimum requirements. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, SWI images, susceptibility enhanced images, pseudo-susceptibility maps, true SWI images, MR angiography (MRA) images, simulated T2 images, simulated T2 FLAIR images, simulated dual inversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD). CROWN, introduced in STAGE, reduces noise some of these outputs, enhancing SNR and/or reducing imaging time. STAGE is indicated for brain imaging. Maximum and minimum intensity projections of some of these outputs will also be provided. The STAGE outputs can be configured to match the conventional acquisition series in MR protocols (i.e. routine brain w/) in terms of contrast, orientation and resolution.
STAGE should always be used in combination with at least one other conventional MR acquisition technique (e.g. T2 FLAIR). STAGE input data can be acquired within a range of collection parameters, within shorter echo acquisitions allowing for less susceptibility affects and higher anatomic signal at the air tissue interface or with longer echo times for higher susceptibility effects around blood products and iron sources.
Spintech, Inc.
2.3
In Commercial Distribution
- 00866463000465 ()
REF 200008
- MRI system application software
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.
Spintech, Inc.
2
Not in Commercial Distribution
- 00866463000441 ()
- MRI system application software
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated computer connected to the user’s local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e. the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to wherever it received the files from (most likely a PACS server). The STAGE system will not contain any user interface. Instead, the data transfer will be initiated by the user’s current DICOM viewing software. The main method for user communication will be through DICOM output files that contain information in the image data. A method for remote connection to the STAGE computer will be included for updating and troubleshooting when an internet connection is available.
Spintech, Inc.
1.1
Not in Commercial Distribution
- 00866463000410 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.6
Not in Commercial Distribution
- 00864747000279 ()
- MRI system application software