Spine Auto Views

GUDID 00195278534064

Spine Auto Views Medical Device

GE MEDICAL SYSTEMS

CT system application software
Primary Device ID00195278534064
NIH Device Record Key82d39fb6-bcb0-4f91-ada7-645984da066d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpine Auto Views
Version Model NumberSee CODE part
Company DUNS266062561
Company NameGE MEDICAL SYSTEMS
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100195278534064 [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 Date2024-03-19
Device Publish Date2024-03-11

Devices Manufactured by GE MEDICAL SYSTEMS

00195278866899 - not applicable2024-06-17 Software Pristina 8.4 - ISO file
00195278719812 - not applicable2024-04-19 Software Pristina ME 9.2 - ISO file
00195278534064 - Spine Auto Views2024-03-19Spine Auto Views Medical Device
00195278534064 - Spine Auto Views2024-03-19 Spine Auto Views Medical Device
00195278795724 - not applicable2024-01-30 Software Pristina 8.3 - ISO file
00195278719263 - Allia2023-12-18 Allia IGS5 UDI
00195278719577 - Allia2023-12-18 Allia IGS3 UDI
00195278719720 - Allia2023-12-18 Allia IGS 7 UDI
00195278719744 - Allia2023-12-18 Allia IGS 7 OR UDI

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