Medipixel XA

GUDID 08800127400040

AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE

Medipixel

Radiology DICOM image processing application software
Primary Device ID08800127400040
NIH Device Record Key76e657af-38ee-4d0e-a5ad-79b5930448ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedipixel XA
Version Model NumberV1.0.0
Company DUNS694862460
Company NameMedipixel
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 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
GS108800127400040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-12
Device Publish Date2023-05-04

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