Kelly Giles

FDA Filings

This page includes the latest FDA filings for Kelly Giles. 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
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