Irt Systems G M B H

FDA Filings

This page includes the latest FDA filings for Irt Systems 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 Number: 3010875109
• FEI Number: 3010875109
• Name: Kelly Giles
• Owner & Operator: iRT Systems GmbH
• Contact Address: Schlossstrasse 1 ; Koblenz DE-RP Rheinland-Pfalz 56068 DE
• Official Correspondent:
  • Thesi Roestel
  • 49-261-915450-x
• US Agent:
  • Kelly Giles
  • 314 3680623
  • regulatory@i-rt.de
• Importing Logistics Registration:
  • Importer: Allegheny General Hospital
  • Address: 320 East North Avenue 02 Level ; Pittsburgh, PA 15212 UNITED STATES
• Importing Logistics Registration:
  • Importer: Brigham & Women?s Hospital
  • Address: 89 Fenwood RD At Brookline Avenue ; Boston, MA 02115 UNITED STATES
• Importing Logistics Registration:
  • Importer: Cedar Sinai
  • Address: 8700 Beverly Blvd, AC 1085 ; Los Angeles, CA 90048 UNITED STATES
• Importing Logistics Registration:
  • Importer: Johns Hopkins Kimmel Cancer Center
  • Address: 401 North Broadway ; Baltimore, MD 21287 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Mayo Clinic Cancer Center
  • Address: 200 First Street S.W. ; Rochester, MN 55905 UNITED STATES
• Importing Logistics Registration:
  • Importer: New York Presbyterian Hopital
  • Address: 432 East 69TH Street ; New York, NY 10065 UNITED STATES
• Importing Logistics Registration:
  • Importer: Reading Hospital
  • Address: 220 North Park Road, Bldg 9A ; Wyomissing, PA 19610 UNITED STATES
• Importing Logistics Registration:
  • Importer: The Cooper Health System, Cooper University Hospit
  • Address: 1 Cooper Plaza ; Camden, NJ 08103 UNITED STATES
• Importing Logistics Registration:
  • Importer: The Washington University
  • Address: 4540 Forest Park Pkwy ; Saint Louis, MO 63124 UNITED STATES
• Importing Logistics Registration:
  • Importer: UC Davis Radiation Oncology
  • Address: 4501 X Street Room 0140 ; Sacramento, CA 95817 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2124 Victor St ; Saint Louis, MO 63104 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID B50510130 iRT Systems GmbH	IQM Integral Quality Monitor	2018-07-06
PMN K162629 | IYE Kelly Giles [iRT Systems GmbH]	Integral Quality Monitor	2016-12-02
PMN K162629 | IYE Kelly Giles [iRT Systems GmbH]	IQM	2016-12-02
PMN K162629 | IYE Kelly Giles [iRT Systems GmbH]	IQM System	2016-12-02
PMN K162629 | IYE Kelly Giles [iRT Systems GmbH]	IQM Integral Quality Monitor	2016-12-02