fullAccess

GUDID 00863284000308

A fully-integrated data display, communication and analysis software platform that enables users to access, analyze and share diagnostic images and radiotherapy treatment plans.

RADIALOGICA LLC

Radiology DICOM image processing application software
Primary Device ID00863284000308
NIH Device Record Keyf4ff80fc-9d29-440e-9d0d-7ae4f1b92f24
Commercial Distribution StatusIn Commercial Distribution
Brand NamefullAccess
Version Model Number1.x
Company DUNS968999610
Company NameRADIALOGICA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com
Phone800-515-9132
Emailsupport@radialogica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100863284000308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-07
Device Publish Date2017-01-04

Devices Manufactured by RADIALOGICA LLC

00863284000308 - fullAccess2019-10-07A fully-integrated data display, communication and analysis software platform that enables users to access, analyze and share diagnostic images and radiotherapy treatment plans.
00863284000308 - fullAccess2019-10-07 A fully-integrated data display, communication and analysis software platform that enables users to access, analyze and share di
00863284000315 - SciMoCa2018-05-07 SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose ge

Trademark Results [fullAccess]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FULLACCESS
FULLACCESS
85525057 4311624 Live/Registered
Radialogica LLC
2012-01-25

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.