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510(k) K000349

MOTORIZED MICRO MULTILEAF COLLIMATOR by Stryker Leibinger — Product Code IXI

K000349 is an FDA 510(k) premarket notification submitted by Stryker Leibinger for the device "MOTORIZED MICRO MULTILEAF COLLIMATOR". The FDA issued a decision of Substantially Equivalent on May 3, 2000. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. Stryker Leibinger has at least 10 other 510(k) clearances on record.

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

  • K133974 — VARIAX DISTAL RADIUS PLATING SYSTEM (March 24, 2014)
  • K052871 — STRYKER CUSTOM TI IMPLANT (December 16, 2005)
  • K043250 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT (April 15, 2005)
  • 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

  • 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