ClearanceBrief
Company ยท US

Xoft, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2009. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
JADSystem, Therapeutic, X-Ray5
IXIBlock, Beam-Shaping, Radiation Therapy2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 16, 2009K090914AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
Xoft, Inc.
JAD
Jun 23, 2009K090417AXXENT FLEXISHIELD MINI
Xoft, Inc.
IXI
Feb 11, 2009K083734AXXENT SURFACE APPLICATOR, MODEL 710257
Xoft, Inc.
JAD
May 9, 2008K072616AXXENT VAGINAL APPLICATOR
Xoft, Inc.
JAD
Feb 29, 2008K072683AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
Xoft, Inc.
JAD
Dec 22, 2005K050843AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
Xoft, Inc.
JAD

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 1, 2011Xoft Inc.
Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up to 50kVp.
Terminated
IXIK090417
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