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510(k) K183034

MOSAIQ Oncology Information System by Elekta, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2018
Date Received
November 1, 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 Elekta, Inc.

  • K190178 — Monaco RTP System (March 29, 2019)
  • K183037 — Monaco RTP System (December 4, 2018)
  • K141855 — CLARITY (October 8, 2014)
  • K123808 — AGILITY (April 4, 2013)
  • K121663 — CLARITY (December 5, 2012)
  • K121328 — AGILITY (June 12, 2012)
  • K111332 — CLARITY OBP SYSTEM (January 30, 2012)
  • K102200 — INTEGRITY MODEL 1014284 (November 4, 2010)
  • K100115 — XVI R4.5 (March 10, 2010)
  • K082122 — MLCI2 (August 29, 2008)

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)