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510(k) K253012

AlignRT Plus (8.0) by Vision Rt, Ltd. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2026
Date Received
September 19, 2025
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 Vision Rt, Ltd.

  • K243301 — MapRT (May 19, 2025)
  • K233622 — AlignRT Plus (March 29, 2024)
  • K231185 — MapRT (June 23, 2023)
  • K212583 — AlignRT Plus (November 10, 2021)
  • K203387 — AlignRT Plus (March 4, 2021)
  • K193431 — AlignRT Plus (January 3, 2020)
  • K181218 — AlignRT Plus (August 7, 2018)

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  • 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)