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510(k) K233722

RADspeed Pro by Shimadzu Corporation — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2024
Date Received
November 21, 2023
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

Other clearances by Shimadzu Corporation

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  • K191877 — FLUOROspeed (August 5, 2019)
  • K190373 — SonialVision G4 (March 15, 2019)
  • K173517 — RADspeed fit (March 30, 2018)
  • K152294 — FDR Visionary Suite (July 15, 2016)
  • K152244 — RADspeed Pro (June 20, 2016)
  • K123508 — TRINIAS (February 26, 2014)

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