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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 June 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 at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2009
Date Received
February 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

Other clearances by Xoft, Inc.

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

Other clearances for product code IXI

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

FDA data resources