ECAT Scintron PET

GUDID 04260484140029

Nuclear Medicine Workstation for Aquisition, Viewing and Processing

MiE medical imaging electronics GmbH

Nuclear medicine system operator console, multi-purpose

• Primary Device ID: 04260484140029
• NIH Device Record Key: 8d159dd5-c3e5-4492-aca0-8a0c8abb5e23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECAT Scintron PET
• Version Model Number: ECAT Scintron PET
• Company DUNS: 537604915
• Company Name: MiE medical imaging electronics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49419499770
• Email: mie@miegermany.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260484140029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130269

FDA Product Code

• KPS: System, Tomography, Computed, Emission

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-27
• Device Publish Date: 2018-07-25

Devices Manufactured by MiE medical imaging electronics GmbH

• 04260484140036 - ECAM-SCINTRON: 2022-12-07 The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnost
• 04260484140043 - MiE - Gamma Camera Systems: 2022-12-07 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 Systems: 2022-12-07 The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or pl
• 04260484140067 - ANCORIS: 2021-06-21 The ‘ANCORIS’ PET Scanner is designed to acquire data, process and display images by appropriated trained medical profession
• 04260484140029 - ECAT Scintron PET: 2018-08-27Nuclear Medicine Workstation for Aquisition, Viewing and Processing
• 04260484140029 - ECAT Scintron PET: 2018-08-27 Nuclear Medicine Workstation for Aquisition, Viewing and Processing
• 04260484140050 - SCINTRON: 2018-08-27 Gamma Camera Workstation for Acquisition, Reviewing and Processing