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510(k) K090417

AXXENT FLEXISHIELD MINI by Xoft, Inc. — Product Code IXI

K090417 is an FDA 510(k) premarket notification submitted by Xoft, Inc. for the device "AXXENT FLEXISHIELD MINI". The FDA issued a decision of Substantially Equivalent on Jun 23, 2009. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. Xoft, Inc. has 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 23, 2009
Date Received
Feb 18, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Beam-Shaping, Radiation Therapy
Device Class
Class II
Regulation Number
892.5710
Review Panel
RA
Submission Type
510(k)

Other clearances by Xoft, Inc.

  • K090914 — AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E (Jul 16, 2009)
  • K083734 — AXXENT SURFACE APPLICATOR, MODEL 710257 (Feb 11, 2009)
  • K072616 — AXXENT VAGINAL APPLICATOR (May 9, 2008)
  • K072683 — AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM (Feb 29, 2008)
  • K050843 — AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM (Dec 22, 2005)

Other clearances for product code IXI

  • K253025 — Ricoh 3D for Healthcare Bolus (Apr 6, 2026)
  • K222639 — VHA Radiotherapy Bolus (Nov 4, 2022)
  • K214093 — VSP Bolus (Mar 30, 2022)
  • K132236 — .DECIMAL PROTON APERTURE (Oct 16, 2013)
  • K131150 — CURA COMPENSATOR (Jul 30, 2013)
  • K123893 — CURA COLLIMATOR (Mar 4, 2013)
  • K123015 — .DECIMAL PHOTON BLOCK (Nov 21, 2012)
  • K111676 — APEX (Sep 30, 2011)
  • K111759 — .DECIMAL ELECTRON APERTURE (Sep 9, 2011)
  • K091403 — MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (Jul 29, 2009)

FDA data resources