Radmedix AccuVue+

GUDID 00810035220379

A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation.

RADMEDIX, LLC

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device ID00810035220379
NIH Device Record Key60168fab-882e-49e0-9528-b38eac80866b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadmedix AccuVue+
Version Model Number5
Company DUNS005057263
Company NameRADMEDIX, 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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]
GS100810035220379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

Devices Manufactured by RADMEDIX, LLC

00810035220379 - Radmedix AccuVue+2020-06-17A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation.
00810035220379 - Radmedix AccuVue+2020-06-17 A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications
00810035220331 - AcuityPDR2020-06-12
00810035220348 - AcuityPDR2020-06-12
00810035220355 - AcuityPDR2020-06-12
00810035220362 - AcuityPDR2020-06-12
00810035220119 - AcuityPDR2020-05-12
00810035220126 - AcuityPDR2020-05-12
00810035220133 - AcuityPDR2020-05-12

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.