Xoft A Subsidiary Of Icad

FDA Filings

This page includes the latest FDA filings for Xoft A Subsidiary Of Icad. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005594788
• FEI Number: 3005594788
• Name: XOFT, A Subsidiary of iCAD
• Owner & Operator: ICAD INC.
• Contact Address: 98 SPIT BROOK ROAD, SUITE 100 --; Nashua NH 03062 US
• Official Correspondent:
  • Heather A Reed
  • x-603-8825200-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 101 Nicholson Ln ; San Jose, CA 95134 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K153570 | JAD XOFT, A Subsidiary of iCAD [ICAD INC.]	Surface Controller	2016-10-12
KPY XOFT, A Subsidiary of iCAD [ICAD INC.]	eFlex, Flexishield	2015-05-27
PMN K122951 | JAD XOFT, A Subsidiary of iCAD [ICAD INC.]	Axxent Controller	2013-04-05
PMN K123442 | JAQ XOFT, A Subsidiary of iCAD [ICAD INC.]	Axxent Cervical Applicator	2013-04-04
PMN K111299 | JAD XOFT, A Subsidiary of iCAD [ICAD INC.]	AXXENT RADIATION SHIELD - RIGID	2011-11-22
PMN K090914 | JAD XOFT, A Subsidiary of iCAD [ICAD INC.]	AXXENT BALLOON APPLICATOR	2011-02-25
PMN K090417 | IXI XOFT, A Subsidiary of iCAD [ICAD INC.]	AXXENT FLEXISHIELD MINI	2011-02-25
PMN K083734 | JAD XOFT, A Subsidiary of iCAD [ICAD INC.]	AXXENT SURFACE APPLICATOR	2011-02-25
PMN K072683 | JAD XOFT, A Subsidiary of iCAD [ICAD INC.]	AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM	2011-02-25
PMN K072616 | JAD XOFT, A Subsidiary of iCAD [ICAD INC.]	AXXENT VAGINAL APPLICATOR	2011-02-25
PMN K050843 | JAD XOFT, A Subsidiary of iCAD [ICAD INC.]	AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM	2011-02-25