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510(k) K243301

MapRT by Vision Rt, Ltd. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2025
Date Received
October 18, 2024
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.

  • 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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