FDA.reportPublic FDA data

Prism Flow

Primary DI
B358PCI01PF0
Brand
Prism Flow
Company
PRISM CLINICAL IMAGING, INC.
Model
4.1
Catalog number
PCI01PF
Device description
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.
Published
2023-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B358PCI01PF0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
262-754-3840advisors@prismclinical.com

Regulatory Flags#

DUNS number
190899638
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B358PCI01PA0Prism Acquire4.1PCI01PA2016-09-21
B358PCI01PP0Prism Process4.1PCI01PP2016-09-21
B358PCI01PV0Prism View4.0PCI01PV2016-09-21
B358PCI01PV410Prism View4.1PCI01PV2019-02-14

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