870DR to 870 CZT Upgrade

GUDID 00840682145725

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system
Primary Device ID00840682145725
NIH Device Record Keyd8554327-b86c-4430-9cfa-15e52b050136
Commercial Distribution StatusIn Commercial Distribution
Brand Name870DR to 870 CZT Upgrade
Version Model NumberH3906DX
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
GS100840682145725 [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 Date2019-05-15
Device Publish Date2019-05-07

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

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