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
Primary Device ID04260484140067
NIH Device Record Key2f4fde6e-5382-4aed-8aeb-199dc2fd306f
Commercial Distribution StatusIn Commercial Distribution
Brand NameANCORIS
Version Model NumberANCORIS
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104260484140067 [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 Date2021-06-21
Device Publish Date2021-06-11

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 - ANCORIS2021-06-21The ‘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 - 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 - SCINTRON2018-08-27 Gamma Camera Workstation for Acquisition, Reviewing and Processing

Trademark Results [ANCORIS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ANCORIS
ANCORIS
88960472 not registered Live/Pending
Avent, Inc.
2020-06-11
ANCORIS
ANCORIS
79373371 not registered Live/Pending
GROUPE AXTOM
2023-02-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.