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510(k) K200726

AcuityPDR by Radmedix, LLC — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2020
Date Received
March 20, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by Radmedix, LLC

  • K231995 — AcuityUDR (October 25, 2023)
  • K231709 — AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 (July 12, 2023)
  • K210919 — AcuityDRe (April 30, 2021)
  • K201058 — Accuvue+ (May 6, 2020)
  • K193360 — Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard (January 2, 2020)

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