ASiR-V

GUDID 00195278303196

ASiR-V Application Container for Smart Subscription

GE HEALTHCARE JAPAN CORPORATION

CT system application software
Primary Device ID00195278303196
NIH Device Record Key26761e24-0005-4b7c-b348-2b10a9a408ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameASiR-V
Version Model Number1.1
Company DUNS696021596
Company NameGE HEALTHCARE JAPAN 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 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
GS100195278303196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, x-ray, tomography, computed

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-02
Device Publish Date2021-08-25

Devices Manufactured by GE HEALTHCARE JAPAN CORPORATION

00195278718129 - Revolution2024-05-03 Ascend Elite Gantry common top asm with UDI
00195278718136 - Revolution2024-05-03 Ascend Plus Gantry common top asm with UDI
00195278718204 - Revolution2024-05-03 Ascend Select Gantry common top asm with UDI
00195278620453 - DLIR2023-07-10 SWMD DLIR Application for Smart Subscription
00195278303196 - ASiR-V2021-09-02ASiR-V Application Container for Smart Subscription
00195278303196 - ASiR-V2021-09-02 ASiR-V Application Container for Smart Subscription
00195278303202 - DLIR2021-09-02 DLIR Application Container for Smart Subscription
00195278303219 - MAR2021-09-02 MAR Application Container for Smart Subscription
00840682146173 - Revolution2020-12-04 NGX Gantry common top asm with UDI

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