PRISM CLINICAL IMAGING, INC.

Address:890 Elm Grove Rd., Suite 209,Elm Grove,WI,53122,US

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- Catalog Number : PCI01PA

Device Description : Prism Acquire® software is used in conjunction with a Magnetic Resonance scanner Prism Acquire® software is used in conjunction with a Magnetic Resonance scanner to acquire blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned for fMRI. The patient’s responses and image data from the MRI scanner are stored for use by Prism Process.

Device Class : 2

Duns Number: 190899638

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

- Catalog Number : PCI01PP

Device Description : Prism Process® software is used in conjunction with a Magnetic Resonance scanner Prism Process® software is used in conjunction with a Magnetic Resonance scanner to process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI), MR diffusion tensor imaging (DTI), and other MRI data sets. Prism Process performs post-processing for quality control and subsequent viewing of fMRI and other data.

Device Class : 2

Duns Number: 190899638

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

- Catalog Number : PCI01PV

Device Description : Prism View provides both analysis and viewing capabilities that promote the inte Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion including diffusion tensor imaging (DTI). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments.

Device Class : 2

Duns Number: 190899638

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

- Catalog Number : PCI01PV

Device Description : Prism View provides both analysis and viewing capabilities that promote the inte Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion including diffusion tensor imaging (DTI). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments.

Device Class : 2

Duns Number: 190899638

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1