Discovery 630

GUDID 00840682115292

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system
Primary Device ID00840682115292
NIH Device Record Key5ef14294-ebc7-46ac-b7e0-ac383bbd50dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiscovery 630
Version Model NumberH3100JY
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
GS100840682115292 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-13

Devices Manufactured by G E MEDICAL SYSTEMS ISRAEL LTD.

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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
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