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510(k) K193360

Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard by Radmedix, LLC — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2020
Date Received
December 4, 2019
Clearance Type
Traditional
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

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  • K200726 — AcuityPDR (April 13, 2020)

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