Home / 510(k) Clearances / K010449

510(k) K010449

IVD (IN VIVO DOSIMETER), MODEL 1131 by Sun Nuclear Corp. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2001
Date Received
February 15, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Sun Nuclear Corp.

  • K112981 — SUN 125C IONIZATION CHAMBER (January 25, 2012)
  • K101992 — 3D SCANNER, MODEL 1230 (October 1, 2010)
  • K092019 — MODEL 1014 PC ELECTROMETER (September 15, 2009)
  • K063021 — PROFILER 2 (November 22, 2006)
  • K051921 — THE EDGE DETECTOR, MODEL 1118 (July 27, 2005)
  • K013689 — RE-ENTRANT CHAMBER (July 2, 2002)
  • K021463 — MODEL 1133 IVD PC VERSION (June 6, 2002)
  • K011332 — RF-IVD WIRELESS DOSIMETER-MODEL 1133 (July 26, 2001)
  • K011466 — QED DIODE DETECTORS, MODELS 1112-1116 (June 6, 2001)
  • K002446 — RE-ENTRANT CHAMBER, MODEL 1008 OR 44D (October 23, 2000)

Other clearances for product code IYE

  • K252977 — Halcyon, Ethos Radiotherapy System (5.0) (January 21, 2026)
  • K252188 — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infin (January 15, 2026)
  • K254010 — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (January 14, 2026)
  • K252988 — ChartCheck (RADCH V1.6) (January 5, 2026)
  • K252919 — IDENTIFY (5.0) (December 16, 2025)
  • K250392 — ZAP-X Radiosurgery System (ZAP-X) (November 3, 2025)
  • K250696 — AccuCheck (October 24, 2025)
  • K250911 — MOSkin Radiation Measurement System (October 17, 2025)
  • K252948 — TrueBeam, TrueBeam STX, Edge and VitalBeam (October 7, 2025)
  • K252174 — AquaCast Mask (September 3, 2025)