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510(k) K200282

Orfit Aerial Couchtop by Orfit Industries NV — Product Code LHN

K200282 is an FDA 510(k) premarket notification submitted by Orfit Industries NV for the device "Orfit Aerial Couchtop". The FDA issued a decision of Substantially Equivalent on April 8, 2020. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Orfit Industries NV has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2020
Date Received
February 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Charged-Particle, 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)
  • 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)
  • K131795 — NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS (September 26, 2013)
  • K991319 — RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS (September 21, 1999)

Other clearances for product code LHN

  • K260174 — PROBEAT-CR (June 11, 2026)
  • K252815 — ProBeam 360 Proton Therapy System v3.0 (April 23, 2026)
  • K253406 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (March 25, 2026)
  • K250986 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (September 12, 2025)
  • K243900 — eMotus Respiratory Motion Management System (June 27, 2025)
  • K242418 — P-Cure Proton Therapy System (PPTS) (May 12, 2025)
  • K232032 — PROBEAT-FR (January 12, 2024)
  • K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom) (October 6, 2023)
  • K221996 — P-Cure Proton Beam Therapy System (March 20, 2023)
  • K220883 — Small Field Applicator (December 15, 2022)

FDA data resources