Head Auto Views 5929651

GUDID 00195278629586

Head Auto Views MD Application Container for Smart Subscription

GE MEDICAL SYSTEMS, INC.

CT system application software
Primary Device ID00195278629586
NIH Device Record Key5a2b45d8-0669-4af5-b98d-3b5c82c8971e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHead Auto Views
Version Model Number1.0
Catalog Number5929651
Company DUNS809785715
Company NameGE MEDICAL SYSTEMS, 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 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
GS100195278629586 [Primary]

FDA Product Code

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 Date2023-09-04
Device Publish Date2023-08-25

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00195278901439 - Omni2024-09-23 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY - WSO
00195278454218 - Omni2024-08-15 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY
00195278840226 - Discovery2024-07-12 XR656HD UDI Label
00195278840233 - Optima2024-07-12 XR646HD UDI Label
00195278792822 - Omni2024-04-19 OMNI GANTRY ELECTRONICS ASSY, MEA

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