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510(k) K922287

E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS by I.Z.I. Corp. — Product Code KPQ

K922287 is an FDA 510(k) premarket notification submitted by I.Z.I. Corp. for the device "E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS". The FDA issued a decision of Substantially Equivalent on October 16, 1992. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. I.Z.I. Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1992
Date Received
May 15, 1992
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. Corp.

  • K022074 — SPHERZ (August 13, 2002)
  • K014022 — MRI LINE MARKER (March 4, 2002)
  • K003736 — MRI LINE MARKER (January 18, 2001)
  • K994117 — MR ENHANCER (February 4, 2000)
  • K993742 — SUPER TISSUE (February 2, 2000)
  • K930752 — CT/MRI TOPOGRAPHIC MARKER (November 19, 1993)

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)

FDA data resources