ImageXL

GUDID 00861787000306

IMAGEXL XRAY SOFTWARE VERSION 4 BASE

PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC

General-purpose dental x-ray system application software
Primary Device ID00861787000306
NIH Device Record Key761bf0e0-63a2-438e-8589-5a3824ea94bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameImageXL
Version Model Number4
Company DUNS066546771
Company NamePROFESSIONAL ECONOMICS BUREAU OF AMERICA INC
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 Numbertrue
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
GS100861787000306 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-09-12

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