Home / 510(k) Clearances / K180106

510(k) K180106

ThinkQA by Dosisoft — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2018
Date Received
January 16, 2018
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 Dosisoft

  • K241765 — PLANET Onco Dose (3.2) (March 14, 2025)
  • K231573 — ThinkQA (Edition 2) (January 18, 2024)
  • K191944 — MU2net (October 24, 2019)
  • K182966 — PLANET Onco Dose (March 6, 2019)
  • K112723 — EPIGRAY (February 8, 2012)
  • K103146 — ISOGRAY TREATMENT PLANNING SYSTEM (March 11, 2011)

Other clearances for product code IYE

  • K252258 — VERIQA RT EPID 3D (April 15, 2026)
  • K253962 — ClearCheck (RADCC V2.7) (April 3, 2026)
  • K253012 — AlignRT Plus (8.0) (March 18, 2026)
  • 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)