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510(k) K231185

MapRT by Vision Rt, Ltd. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2023
Date Received
April 26, 2023
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.

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  • K193431 — AlignRT Plus (January 3, 2020)
  • K181218 — AlignRT Plus (August 7, 2018)

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