ECAM-SCINTRON

GUDID 04260484140036

The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnostic nuclear medicine used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients. The ECAM SCINTRON Gamma Camera System is substantially equivalent to the legally market device e.cam, K963983, from Siemens and our device SCINTRON, K101 01 3. The changes incorporated into the remanufactured ECAM Gamma Camera include economical and ecological issues. This closes the gap between more durable electronics and mechanics lifetimes and shortened development cycles.

MiE medical imaging electronics GmbH

Stationary gamma camera system

• Primary Device ID: 04260484140036
• NIH Device Record Key: bb6f8e2d-efb2-46b7-8783-402c0e9f780c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECAM-SCINTRON
• Version Model Number: ECAM-SCINTRON
• 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	04260484140036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101768

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: 2022-12-07
• Device Publish Date: 2022-11-29

Devices Manufactured by MiE medical imaging electronics GmbH

• 04260484140036 - ECAM-SCINTRON: 2022-12-07The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnostic nuclear medicine used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients. The ECAM SCINTRON Gamma Camera System is substantially equivalent to the legally market device e.cam, K963983, from Siemens and our device SCINTRON, K101 01 3. The changes incorporated into the remanufactured ECAM Gamma Camera include economical and ecological issues. This closes the gap between more durable electronics and mechanics lifetimes and shortened development cycles.
• 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: 2018-08-27 Nuclear Medicine Workstation for Aquisition, Viewing and Processing
• 04260484140050 - SCINTRON: 2018-08-27 Gamma Camera Workstation for Acquisition, Reviewing and Processing