Optima

GUDID 00840682116510

GE HEALTHCARE JAPAN CORPORATION

Full-body CT system
Primary Device ID00840682116510
NIH Device Record Key813a882d-9fa3-4384-8dcd-6bb8b66514a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptima
Version Model NumberCT660 Cj2.5 Upgrade
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS100840682116510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, x-ray, tomography, computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-10

Devices Manufactured by GE HEALTHCARE JAPAN CORPORATION

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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-V2021-09-02 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

Trademark Results [Optima]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPTIMA
OPTIMA
98481642 not registered Live/Pending
CHRYSO
2024-04-03
OPTIMA
OPTIMA
98314629 not registered Live/Pending
Optima Telecom Incorporated
2023-12-14
OPTIMA
OPTIMA
98269903 not registered Live/Pending
ADFA, INC
2023-11-14
OPTIMA
OPTIMA
98235715 not registered Live/Pending
Mountain View Seeds LLC
2023-10-23
OPTIMA
OPTIMA
98090576 not registered Live/Pending
Corus Europe B.V.
2023-07-18
OPTIMA
OPTIMA
97797294 not registered Live/Pending
ACCO Brands Corporation
2023-02-16
OPTIMA
OPTIMA
97716826 not registered Live/Pending
PolyAtom, LLC
2022-12-14
OPTIMA
OPTIMA
97654731 not registered Live/Pending
Sunmarks, LLC
2022-10-31
OPTIMA
OPTIMA
97654718 not registered Live/Pending
Sunmarks, LLC
2022-10-31
OPTIMA
OPTIMA
97618197 not registered Live/Pending
Primo Doors, LLC
2022-10-04
OPTIMA
OPTIMA
97618176 not registered Live/Pending
Primo Doors, LLC
2022-10-04
OPTIMA
OPTIMA
97598706 not registered Live/Pending
BodyVibe International, LLC
2022-09-20

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