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510(k) K181218

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2018
Date Received
May 7, 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 Vision Rt, Ltd.

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  • K203387 — AlignRT Plus (March 4, 2021)
  • K193431 — AlignRT Plus (January 3, 2020)

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