DEVICE: Prism Process (B358PCI01PP0)
Device Identifier (DI) Information
Prism Process
4.1
In Commercial Distribution
PCI01PP
PRISM CLINICAL IMAGING, INC.
4.1
In Commercial Distribution
PCI01PP
PRISM CLINICAL IMAGING, INC.
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 Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Radiology DICOM image processing application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography]. |
FDA Product Code
[?]Product Code | Product Code Name |
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LNH | System, Nuclear Magnetic Resonance Imaging |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
95d5ec54-64a6-40e2-ad2d-498973897fb1
March 29, 2018
2
September 21, 2016
March 29, 2018
2
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
262-754-3840
advisors@prismclinical.com
advisors@prismclinical.com