Image Information Systems Europe G M B H

FDA Filings

This page includes the latest FDA filings for Image Information Systems Europe G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006165530
FEI Number3006165530
NameIMAGE INFORMATION SYSTEMS EUROPE GmbH
Owner & OperatorIMAGE INFORMATION SYSTEMS EUROPE LTD.
Contact AddressLange Strasse 16
Rostock DE-MV Mecklenburg-Vorpommern 18055 DE
US Agent
Importing Logistics Registration
ImporterIMAGE Information Systems North America LP
Address10341 Avondale Ave.
Charlotte, NC 28210 UNITED STATES
Importer TypeRetailer
Importing Logistics Registration
ImporterPLUM Medical Solutions Inc.
Address10341 Avondale Ave
Charlotte, NC 28210 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressLANGE STRASSE 16
ROSTOCK Mecklenburg-Vorpommern, 18055 DE
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
IMAGE Information Systems Europe GmbH
 iQ-SYSTEM PACS 2023-08-08
IMAGE Information Systems Europe GmbH
 iQ-SYSTEM PACS 2021-06-18
IMAGE Information Systems Europe GmbH
 iQ-SYSTEM PACS 2019-10-29
IMAGE INFORMATION SYSTEMS EUROPE GmbH [IMAGE INFORMATION SYSTEMS EUROPE LTD.]
MED-TAB2018-11-27
IMAGE INFORMATION SYSTEMS EUROPE GmbH [IMAGE INFORMATION SYSTEMS EUROPE LTD.]
MED-TAB v.22018-11-27
IMAGE Information Systems Europe GmbH
 iQ-SYSTEM PACS 2018-08-13
IMAGE Information Systems Europe GmbH
 iQ-SYSTEM PACS 2018-07-06
IMAGE Information Systems Europe GmbH
 iQ-SYSTEM PACS 2018-07-06
IMAGE Information Systems Europe GmbH
 iQ-SYSTEM PACS 2018-07-06
IMAGE INFORMATION SYSTEMS EUROPE GmbH [IMAGE INFORMATION SYSTEMS EUROPE LTD.]
IQ-SYSTEM PACS2006-10-04

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