Home / 510(k) Clearances / K131795

510(k) K131795

NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS by Orfit Industries NV — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2013
Date Received
June 18, 2013
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 Orfit Industries NV

  • K202068 — The AIO Solution 3.0 (August 14, 2020)
  • K200282 — Orfit Aerial Couchtop (April 8, 2020)
  • K191158 — The AIO Solution (August 6, 2019)
  • K171734 — HP PRO Positioning Device (July 25, 2017)
  • K162355 — Raycast MammoRx Carbon Fibre Breast Board (November 22, 2016)
  • K162862 — Raycast High Precision Lung Board Solution (November 9, 2016)
  • K151946 — Thermofit (November 9, 2015)
  • K151207 — Proton Immobilization Solution (July 28, 2015)
  • K141787 — SAGITTILT (August 7, 2014)
  • K991319 — RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS (September 21, 1999)

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)