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510(k) K111676

APEX by Elekta Limited — Product Code IXI

K111676 is an FDA 510(k) premarket notification submitted by Elekta Limited for the device "APEX". The FDA issued a decision of Substantially Equivalent on September 30, 2011. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. Elekta Limited has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2011
Date Received
June 15, 2011
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 Elekta Limited

  • K210500 — Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD (June 11, 2021)
  • K192482 — Elekta Unity (December 5, 2019)
  • K192242 — Synergy Platform, Synergy, Infinity, VersaHD (November 22, 2019)
  • K182076 — Elekta Unity (December 4, 2018)
  • K153011 — iViewDose R1.0 (December 11, 2015)
  • K131965 — XVI R5.0 (September 25, 2013)
  • K112613 — INTEGRITY(TM) (December 16, 2011)

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)
  • K111759 — .DECIMAL ELECTRON APERTURE (September 9, 2011)
  • K091403 — MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (July 29, 2009)
  • K091911 — BOLUS COMPENSATOR (July 21, 2009)

FDA data resources