DEVICE: Prism Process (B358PCI01PP0)

Device Identifier (DI) Information

Prism Process
4.1
In Commercial Distribution
PCI01PP
PRISM CLINICAL IMAGING, INC.
B358PCI01PP0
HIBCC

1
190899638 *Terms of Use
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.
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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].
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FDA Product Code

[?]
Product Code Product Code Name
LNH System, Nuclear Magnetic Resonance Imaging
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K122026 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

95d5ec54-64a6-40e2-ad2d-498973897fb1
July 06, 2018
3
September 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
262-754-3840
advisors@prismclinical.com
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