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 Number3005594788
FEI Number3005594788
NameXOFT, A Subsidiary of iCAD
Owner & OperatorICAD INC.
Contact Address98 SPIT BROOK ROAD, SUITE 100 --
Nashua NH 03062 US
Official Correspondent
  • Heather A Reed
  • x-603-8825200-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address101 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
DeviceDate
XOFT, A Subsidiary of iCAD [ICAD INC.]
Surface Controller2016-10-12
XOFT, A Subsidiary of iCAD [ICAD INC.]
eFlex, Flexishield2015-05-27
XOFT, A Subsidiary of iCAD [ICAD INC.]
Axxent Controller2013-04-05
XOFT, A Subsidiary of iCAD [ICAD INC.]
Axxent Cervical Applicator2013-04-04
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT RADIATION SHIELD - RIGID2011-11-22
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT BALLOON APPLICATOR2011-02-25
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT FLEXISHIELD MINI2011-02-25
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT SURFACE APPLICATOR2011-02-25
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM2011-02-25
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT VAGINAL APPLICATOR2011-02-25
XOFT, A Subsidiary of iCAD [ICAD INC.]
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM2011-02-25

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