AccessGUDID - DEVICE: Prism Process (B358PCI01PP0)

GUDID

Device Identifier (DI) Information

Brand Name: Prism Process
Version or Model: 4.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PCI01PP
Company Name: PRISM CLINICAL IMAGING, INC.

Primary DI Number: B358PCI01PP0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 190899638 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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	A software application intended to add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a patient’s body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it allows for both image management (viewing, communication, printing) and image manipulation and quantification. It is designed to process 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].

GMDN Preferred Term Name

GMDN Definition

Radiology DICOM image processing application software

A software application intended to add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a patient’s body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it allows for both image management (viewing, communication, printing) and image manipulation and quantification. It is designed to process 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
LNH	System, Nuclear Magnetic Resonance Imaging

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 95d5ec54-64a6-40e2-ad2d-498973897fb1
Public Version Date: September 24, 2018
Public Version Number: 4
DI Record Publish Date: September 21, 2016