| Primary Device ID | B358PCI01PP0 | 
| NIH Device Record Key | 95d5ec54-64a6-40e2-ad2d-498973897fb1 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Prism Process | 
| Version Model Number | 4.1 | 
| Catalog Number | PCI01PP | 
| Company DUNS | 190899638 | 
| Company Name | PRISM CLINICAL IMAGING, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | |
| Phone | 262-754-3840 | 
| advisors@prismclinical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | B358PCI01PP0 [Primary] | 
| LNH | System, Nuclear Magnetic Resonance Imaging | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 6 | 
| Public Version Date | 2019-10-07 | 
| Device Publish Date | 2016-09-21 | 
| B358PCI01PF0 - Prism Flow | 2023-06-16 Prism Flow® is the DICOM communications and storage and Prism workflow manager. It provides integrated access, application conf | 
| B358PCI01PA0 - Prism Acquire | 2019-10-07 Prism Acquire® software is used in conjunction with a Magnetic Resonance scanner to acquire blood oxygen level dependent (BOLD) | 
| B358PCI01PP0 - Prism Process | 2019-10-07Prism 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. | 
| B358PCI01PP0 - Prism Process | 2019-10-07 Prism Process® software is used in conjunction with a Magnetic Resonance scanner to process blood oxygen level dependent (BOLD) | 
| B358PCI01PV0 - Prism View | 2019-10-07 Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and funct | 
| B358PCI01PV410 - Prism View | 2019-10-07 Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and funct | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  PRISM PROCESS  78899481  3327820 Live/Registered | PRISM CLINICAL IMAGING, INC. 2006-06-02 |