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510(k) Data Aggregation
K Number
K201807Device Name
ANCORIS
Manufacturer
Date Cleared
2020-08-27
(57 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
MiEGmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
The proposed device 'ANCORIS' is a PET system providing volume measurements of metabolic and physiologic processes. It is the same as the legally market device, name 'ECAT ACCEL PET scanner', K002584, from CTI PET Systems (now Siemens Medical), combined with the legally market device, name 'ECAT Scintron PET', K130269 from MiE GmbH. It is designed to close the economical gap between the demand and availability of stand-alone PET scanner. 'ANCORIS' PET Scanner is designed to perform acquisitions, image The reconstruction, processing, viewing and analysis of data. It uses the same technology and has the same performance as well as indications for use as the leqally market devices. The system includes the gantry with transmission scan capability, the currently market integrated workstation 'ECAT Scintron PET' (K130269) and the new designed PHS. The system is available as a three detector-ring system with a 16.2cm field of view same as used in currently marketed device ECAT ACCEL PET Scanner (K002584).
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