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STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced Tl weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of TI, R2*, and proton density (PD). When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis. STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition ( e.g., T2 FLAIR).

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.

STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM ) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD). When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis. STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition (e.g., T2 FLAIR).

STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated medical grade computer (STAGE Module) 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 the PACS server. The data transfer is initiated by the user's current DICOM viewing software.

The SpinTech, Inc. SPIN-SWI application is intended for use in the post-acquisition image enhancement of MRI acquired 3D gradient-echo images of the brain. When used in combination with other clinical information, the SPIN-SWI application may aid the qualified radiologist with diagnosis by providing enhanced visualization of structures containing venous blood such as cerebral venous vasculature.

The SPIN-SWI device includes a post-processing algorithm that enhances the contrast of tissues with different susceptibilities from 3D gradient-echo MRI images. The susceptibility of a biological tissue relates to the concentration of iron within it. which can be present in the form of deoxyhemoglobin, ferritin, hemosiderin, or other molecules. An MRI scan results in both magnitude and phase images. While magnitude is most commonly used clinically, the phase information can also be useful as it relates directly to the magnetic field. When tissues or objects of differing magnetic susceptibility are present, they perturb the field around them. This effect can be seen directly from phase images. While this perturbation already leads to signal loss in magnitude images, thus creating contrast, the phase information can still be used to enhance this contrast for local susceptibility changes. Enhancing this contrast allows us to visualize structures containing venous blood such as cerebral venous vasculature that may have not been visible prior to enhancement. Some technical challenges of SWI include eliminating the effects of unwanted background fields and choosing parameters to create optimal contrast. SPIN-SWI software works in conjunction with an FDA cleared third-party DICOM viewer as an image postprocessing solution in a PC workstation. The DICOM viewer (ORIS Visual) was FDA cleared on 4/29/2010 via K100335 and is used to transmit DICOM data and display the input and output images, the SPIN-SWI software application performs the SWI post-processing on 3D GRE input images to reconstruct the SWI output images.

The SafetyWand™ is intended to inject local anesthetic agents subcutaneously or intramuscularly for dental applications. It is a sterile single use handpiece assembly for use with the Milestone Compudent™ computer controlled injection system. The SafetyWand™ incorporates safety engineering sharps protection features to aid in the prevention of needlesticks.

The SafetyWand™ disposable handpiece is a safety engineered syringe component designed for use with the CompuDent™ computer controlled injection system (K992819). The CompuDent® device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The hanbdpiece is made of rigid PVC. The anesthetic cartridge holder, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge svringes. The device provides audible status indicators, including optional voice announcement of injection rate, and volume of anesthetic dispensed. The SafetyWand™ handpiece incorporates a protective barrel inside of which a movable needle hub assembly can be extended and locked in place for use in performing iniections. When not in use, or for disposal, the needle can be retracted within the barrel to aid in the prevention of needlesticks.

For injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block.

The Wand™ is a computer controlled syringe consisting of a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes.

To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.

The Wand Plus™ is a computer controlled syringe consisting of a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes. The device provides audible status indicators, including optional voice announcement, of injection rate, and volume of anesthetic dispensed.