Home / 510(k) Clearances / K080929

510(k) K080929

ONCENTRA GYN by Nucletron Corporation — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2008
Date Received
April 1, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Nucletron Corporation

  • K103515 — EQUAL DOSE (September 15, 2011)
  • K090706 — ONCENTRA SIMULATION 2.3 (June 15, 2009)
  • K091154 — UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL (May 18, 2009)
  • K082642 — ONCENTRA RT VIEWER 1.0 (November 7, 2008)
  • K080934 — VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT (May 28, 2008)
  • K081281 — OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) (May 20, 2008)
  • K080871 — TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS (April 29, 2008)
  • K073273 — EQUAL DOSE 1.0 (December 11, 2007)
  • K073107 — VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 (December 7, 2007)
  • K061354 — MICROSELECTRON V3, MODEL 106.990 (August 17, 2006)

Other clearances for product code MUJ

  • K252002 — Monaco RTP System (6.3) (February 19, 2026)
  • K260308 — TrueFit Bolus (February 19, 2026)
  • K253091 — ART-Plan+ (v3.1.0) (December 23, 2025)
  • K252109 — RayStation (2024A SP3) (December 22, 2025)
  • K252863 — ClearCalc Model RADCA V2.6 (December 19, 2025)
  • K250963 — PlanOne 1 (November 20, 2025)
  • K250064 — Dose+ (1.0) (September 4, 2025)
  • K250440 — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (June 17, 2025)
  • K242992 — RayCare (2024A SP1) (April 17, 2025)
  • K242748 — Oncospace (April 11, 2025)