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510(k) K072445

INTEGRATED BRACHYTHERAPY UNIT - DIGITAL by Nucletron Corp. — Product Code KPQ

K072445 is an FDA 510(k) premarket notification submitted by Nucletron Corp. for the device "INTEGRATED BRACHYTHERAPY UNIT - DIGITAL". The FDA issued a decision of Substantially Equivalent on September 14, 2007. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. Nucletron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2007
Date Received
August 30, 2007
Clearance Type
Special
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 Nucletron Corp.

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  • K213942 — Esteya (January 11, 2022)
  • K201272 — Geneva (July 16, 2020)
  • K161688 — Advanced Gynecological Applicator (January 27, 2017)
  • K151272 — Henschke Titanium Applicator Set (June 23, 2015)
  • K142439 — Martinez Prostate Template Set (March 10, 2015)
  • K140803 — LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM (June 26, 2014)
  • K132816 — ONCENTRA BRACHY (June 13, 2014)
  • K132889 — FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR (February 26, 2014)
  • K132874 — LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SE (February 21, 2014)

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)
  • 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)
  • K033339 — ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (December 30, 2003)

FDA data resources