Aurora

GUDID 00195278878502

AURORA NM GANTRY FINAL

G E MEDICAL SYSTEMS ISRAEL LTD.

Full-body CT system
Primary Device ID00195278878502
NIH Device Record Keya4aee6ec-a9ed-43ff-971c-79caace10d4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAurora
Version Model NumberSPECT with Revolution Ascend CT
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
GS100195278878502 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-05
Device Publish Date2025-02-25

Devices Manufactured by G E MEDICAL SYSTEMS ISRAEL LTD.

00195278878502 - Aurora2025-03-05AURORA NM GANTRY FINAL
00195278878502 - Aurora2025-03-05 AURORA NM GANTRY FINAL
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

Trademark Results [Aurora]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AURORA
AURORA
98871520 not registered Live/Pending
Arctic Wolf Networks, Inc.
2024-11-25
AURORA
AURORA
98853668 not registered Live/Pending
Nuravine LLC
2024-11-14
AURORA
AURORA
98849456 not registered Live/Pending
COOPERATIVA CENTRAL AURORA ALIMENTOS
2024-11-12
AURORA
AURORA
98633708 not registered Live/Pending
Lishui Longyiren Equipment Co., Ltd.
2024-07-04
AURORA
AURORA
98630900 not registered Live/Pending
Aurora Outdoors LLC
2024-07-03
AURORA
AURORA
98599374 not registered Live/Pending
Racemasters, Inc.
2024-06-13
AURORA
AURORA
98594731 not registered Live/Pending
Shared Plate Hospitality, LLC
2024-06-11
AURORA
AURORA
98544467 not registered Live/Pending
Native Instruments USA, Inc.
2024-05-10
AURORA
AURORA
98537546 not registered Live/Pending
Paulo Cesar Ferreira
2024-05-07
AURORA
AURORA
98484669 not registered Live/Pending
Teal Communications, Inc.
2024-04-04
AURORA
AURORA
98447552 not registered Live/Pending
Praesto LLC
2024-03-13
AURORA
AURORA
98393802 not registered Live/Pending
Strings by Aurora
2024-02-06

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