Home / 510(k) Clearances / K964972

510(k) K964972

SHADOWFORM by I.Z.I. Medical Products Corp. — Product Code KPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1997
Date Received
December 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Simulation, Radiation Therapy
Device Class
Class II
Regulation Number
892.5840
Review Panel
RA
Submission Type

Other clearances by I.Z.I. Medical Products Corp.

  • K990242 — TOPOGRAPHIC IMAGING MARKER (March 3, 1999)
  • K990298 — TOPOGRAPHIC IMAGING MARKER (March 3, 1999)
  • K962606 — TOPOGRAPHIC IMAGING MARKER (August 7, 1996)

Other clearances for product code KPQ

  • K132944 — ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION (March 14, 2014)
  • K132045 — ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS (September 4, 2013)
  • K101038 — RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER (August 17, 2010)
  • K090706 — ONCENTRA SIMULATION 2.3 (June 15, 2009)
  • K083591 — IKOENGELO, VERSION 2 (December 29, 2008)
  • K072445 — INTEGRATED BRACHYTHERAPY UNIT - DIGITAL (September 14, 2007)
  • K061006 — IKOENGELO (June 5, 2006)
  • K052361 — SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM (October 24, 2005)
  • K052345 — ADVANTAGE SIM MD (September 14, 2005)
  • K033470 — SIMULIX EVOLUTION (February 4, 2004)