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510(k) K972016

AUTIMO 2.5-D AND AUTIMO 3-D by C.L. Mcintosh & Assoc., Inc. — Product Code IXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1997
Date Received
May 30, 1997
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 C.L. Mcintosh & Assoc., Inc.

  • K970131 — ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE (June 16, 1997)
  • K961725 — OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION (August 1, 1996)
  • K942227 — NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM (June 28, 1996)

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  • 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)