Optima

GUDID 00840682139281

G E MEDICAL SYSTEMS ISRAEL LTD.

Full-body CT system
Primary Device ID00840682139281
NIH Device Record Key693f4f70-e1e5-4f3c-8fe1-834680715d96
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptima
Version Model NumberNMCT640
Company DUNS532102365
Company NameG E MEDICAL SYSTEMS ISRAEL LTD.
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
GS100840682139281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPSSystem, tomography, computed, emission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-27
Device Publish Date2018-07-27

Devices Manufactured by G E MEDICAL SYSTEMS ISRAEL LTD.

00195278870490 - StarGuide MDD to MDR Upgrade2024-05-24 StarGuide SW and Labels Upgrade
00195278755544 - StarGuide2024-04-26 StarGuide NM GANTRY MDR FINAL
00195278794772 - D630 to D670 DR Upgrade2024-03-26 D630 to D670 DR NM GANTRY UPGRADE KIT
00195278788252 - NM2023-11-23 830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
00195278788269 - NMCT2023-11-22 870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE
00195278488619 - MyoSPECT2023-09-22 MyoSPECT MDR GANTRY
00195278488626 - MyoSPECT ES2023-09-22 MyoSPECT ES MDR GANTRY
00195278722546 - MyoSEPCT ES to MyoSPECT Upgrade2023-09-22 MyoSPECT ES to MyoSPECT Upgrade kit

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.