SCINTRON

GUDID 04260484140050

Gamma Camera Workstation for Acquisition, Reviewing and Processing

MiE medical imaging electronics GmbH

Nuclear medicine system operator console, multi-purpose
Primary Device ID04260484140050
NIH Device Record Key1c7632fe-c1e0-46c2-8ccf-431d2b6df073
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCINTRON
Version Model NumberSCINTRON
Company DUNS537604915
Company NameMiE medical imaging electronics GmbH
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

Customer Support Contacts

Phone+49419499770
Emailmie@miegermany.de

Device Identifiers

Device Issuing AgencyDevice ID
GS104260484140050 [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 Date2018-07-25

Devices Manufactured by MiE medical imaging electronics GmbH

04260484140036 - ECAM-SCINTRON2022-12-07 The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnost
04260484140043 - MiE - Gamma Camera Systems2022-12-07 The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or pl
04260484140074 - MiE - Gamma Camera Systems2022-12-07 The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or pl
04260484140067 - ANCORIS2021-06-21 The ‘ANCORIS’ PET Scanner is designed to acquire data, process and display images by appropriated trained medical profession
04260484140029 - ECAT Scintron PET2018-08-27 Nuclear Medicine Workstation for Aquisition, Viewing and Processing
04260484140050 - SCINTRON2018-08-27Gamma Camera Workstation for Acquisition, Reviewing and Processing
04260484140050 - SCINTRON2018-08-27 Gamma Camera Workstation for Acquisition, Reviewing and Processing

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