prismclinical.comPRISM ACQUIRE PRISM PROCESS PRISM VIEW
PRISM CLINICAL IMAGING, INC.
PRISM CLINICAL IMAGING, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005517190 | 3005517190 | PRISM CLINICAL IMAGING, INC. | 1 | N | 2026-01-01 | 890 Elm Grove Rd., Suite 209 Elm Grove WI US 53122 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B358PCI01PA0 | Prism Acquire - Prism Acquire® software is used in conjunction with a Magnetic Resonance scanner to acquire blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned for fMRI. The patient’s responses and image data from the MRI scanner are stored for use by Prism Process. | 262-754-3840 | advisors@prismclinical.com |
| B358PCI01PF0 | Prism Flow - Prism Flow® is the DICOM communications and storage and Prism workflow manager. It provides integrated access, application configuration, and audit logging across physical locations and the cloud. The dedicated DICOM store holds raw, intermediate and processed results, as well as providing DICOM interoperability with scanners, PACS, treatment planning, and surgical navigation systems through powerful configurable sender/receiver and forwarding functions. | 262-754-3840 | advisors@prismclinical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 24413 | 1051209041 | K122026 | PRISM ACQUIRE PRISM PROCESS PRISM VIEW | LNH | 2012-09-21 |
| 24413 | 1295510402 | K082964 | PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) | LNH | 2009-03-09 |
| 24413 | 2061114495 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LNH | 2 | 2012-09-21 |
PMN#
PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)
PRISM CLINICAL IMAGING, INC.
GUDID#
Prism Flow - Prism Flow® is the DICOM communications and storage and Prism workflow manager. It provides integrated access, application configuration, and audit logging across physical locations and the cloud. The dedicated DICOM store holds raw, intermediate and processed results, as well as providing DICOM interoperability with scanners, PACS, treatment planning, and surgical navigation systems through powerful configurable sender/receiver and forwarding functions.
2023-06-08
Prism Acquire - Prism Acquire® software is used in conjunction with a Magnetic Resonance scanner to acquire blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned for fMRI. The patient’s responses and image data from the MRI scanner are stored for use by Prism Process.
2016-09-21
Prism Process - 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.
2016-09-21
Prism View - 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.
2016-09-21
Prism View - 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.
2019-02-14