InfiMed Digital Imaging System, Precision MPi, DSA, CCD Camera

GUDID 00854344007115

VAREX IMAGING CORPORATION

X-ray system computer, diagnostic, general-purpose
Primary Device ID00854344007115
NIH Device Record Key80ac6f92-457f-4125-839d-0159f8985ead
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfiMed Digital Imaging System, Precision MPi, DSA, CCD Camera
Version Model NumberPrecision MPi DSA
Company DUNS080506857
Company NameVAREX IMAGING CORPORATION
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854344007115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-24

Devices Manufactured by VAREX IMAGING CORPORATION

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00854344007672 - Varex Digital Imaging Software, Nexus DR, v4.102023-06-07
00854344007696 - Varex Digital Imaging Software, Nexus DR, v4.122023-06-07

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