AccessGUDID - DEVICE: FlexView Diagnostic (00860011710202)

GUDID

Device Identifier (DI) Information

Brand Name: FlexView Diagnostic
Version or Model: 1.2.7
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Radical Imaging LLC

Primary DI Number: 00860011710202
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080438649 *Terms of Use

Device Description: FlexView Diagnostic is a stand-alone Web-based DICOM medical image viewer which allows downloading, reviewing, manipulating, and visualizing medical multi-modality image data in DICOM format and other data. FlexView Diagnostic is a server-based solution that may integrate with healthcare facility software systems and display DICOM images. FlexView Diagnostic enables healthcare professionals to access, manipulate, and measure DICOM images and collaborate using diagnostic quality medical images without installing client software. FlexView Diagnostic enables healthcare professionals to access, manipulate, and measure DICOM images and collaborate using diagnostic quality medical images without installing client software.

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
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233226	000

Device Exempt from Premarket Submission: No 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: 99465071-0d44-4d4e-b646-61a8b78c033c
Public Version Date: April 26, 2024
Public Version Number: 1
DI Record Publish Date: April 18, 2024