ANCORIS

GUDID 04260484140067

The ‘ANCORIS’ PET Scanner is designed to acquire data, process and display images by appropriated trained medical professionals via measuring the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.

MiE medical imaging electronics GmbH

PET system PET system PET system PET system PET system PET system PET system PET system PET system PET system PET system PET system PET system PET system PET system PET system

• Primary Device ID: 04260484140067
• NIH Device Record Key: 2f4fde6e-5382-4aed-8aeb-199dc2fd306f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANCORIS
• Version Model Number: ANCORIS
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260484140067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201807

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: 2021-06-21
• Device Publish Date: 2021-06-11

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: 2021-06-21The ‘ANCORIS’ PET Scanner is designed to acquire data, process and display images by appropriated trained medical professionals via measuring the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.
• 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