AccessGUDID - DEVICE: Prism Flow (B358PCI01PF0)

GUDID

Device Identifier (DI) Information

Brand Name: Prism Flow
Version or Model: 4.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PCI01PF
Company Name: PRISM CLINICAL IMAGING, INC.

Primary DI Number: B358PCI01PF0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 190899638 *Terms of Use

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.

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57812	Radiology DICOM image processing application software	A 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 quality manipulation and quantification (e.g., non-interpretive graphical overlays).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMD	System, Digital Image Communications, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 4d550874-192a-4241-9d31-73e446c847bd
Public Version Date: December 04, 2023
Public Version Number: 2
DI Record Publish Date: June 08, 2023