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510(k) K000349

MOTORIZED MICRO MULTILEAF COLLIMATOR by Stryker Leibinger — Product Code IXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2000
Date Received
February 3, 2000
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 Stryker Leibinger

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  • K041651 — STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM (September 30, 2004)
  • K040022 — STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM (March 12, 2004)
  • K022579 — STRYKER NAVIGATION SYSTEM-KNEE MODULE (June 2, 2003)
  • K023449 — NON-INVASIVE PATIENT FIXATION SYSTEM (January 13, 2003)
  • K013775 — TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM (January 8, 2002)
  • K012380 — MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL F (December 3, 2001)
  • K000594 — LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE (December 8, 2000)

Other clearances for product code IXI

  • 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)
  • K091911 — BOLUS COMPENSATOR (July 21, 2009)