Prism View PCI01PV
GUDID B358PCI01PV0
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.
PRISM CLINICAL IMAGING, INC.
Radiology DICOM image processing application software| Primary Device ID | B358PCI01PV0 |
| NIH Device Record Key | 982398d3-2e2c-422e-a9c3-51c96fa78f64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prism View |
| Version Model Number | 4.0 |
| Catalog Number | PCI01PV |
| 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 |
Customer Support Contacts
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B358PCI01PV0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122026
FDA Product Code
| LLZ | System, Image Processing, Radiological |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2016-09-21 |
On-Brand Devices [Prism View]
| B358PCI01PV410 | Prism View provides both analysis and viewing capabilities that promote the integration of anato |
| B358PCI01PV0 | Prism View provides both analysis and viewing capabilities that promote the integration of anato |
Trademark Results [Prism View]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRISM VIEW 78899494 3327821 Live/Registered |
PRISM CLINICAL IMAGING, INC. 2006-06-02 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.