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510(k) K231995

AcuityUDR by Radmedix, LLC — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2023
Date Received
July 5, 2023
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Radmedix, LLC

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  • K200726 — AcuityPDR (April 13, 2020)
  • K193360 — Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard (January 2, 2020)

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  • K250738 — YSIO X.pree (July 31, 2025)
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