FDA.reportPublic FDA data

XOFT, A Subsidiary of iCAD

Matched from indexed company URL: XOFT, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30055947883005594788XOFT, A Subsidiary of iCAD1N2020-04-25101 Nicholson Ln San Jose CA US 95134

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1263991449182471K153570Axxent Electronic Brachytherapy System Model 110 XP 1200JAD2016-02-25
1263991954234512K123442XOFT AXXENT CERVICAL APPLICATORSJAQ2013-02-27
1263991316105548K122951XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110JAD2013-01-17
1263991692577135K111299AXXENT RADIATION SHIELD - RIGIDJAD2011-07-20
1263991395305786K090914AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067EJAD2009-07-16
1263991953147789K090417AXXENT FLEXISHIELD MINIIXI2009-06-23
1263991478517331K083734AXXENT SURFACE APPLICATOR, MODEL 710257JAD2009-02-11
1263991307142733K072683AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMJAD2008-02-29
1263991337378114K072616AXXENT VAGINAL APPLICATORJAD2008-05-09
1263992028069590K050843AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMJAD2005-12-22
1263991931239364

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAD82016-02-25
JAQ12013-02-27
IXI12009-06-23

PMN#