Home / 510(k) Clearances / K173517

510(k) K173517

RADspeed fit by Shimadzu Corporation — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2018
Date Received
November 14, 2017
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

  • K233719 — FDR Visionary Suite (March 28, 2024)
  • K233722 — RADspeed Pro (February 23, 2024)
  • K191877 — FLUOROspeed (August 5, 2019)
  • K190373 — SonialVision G4 (March 15, 2019)
  • K152294 — FDR Visionary Suite (July 15, 2016)
  • K152244 — RADspeed Pro (June 20, 2016)
  • K123508 — TRINIAS (February 26, 2014)

Other clearances for product code KPR

  • K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 dete (January 20, 2026)
  • K252000 — uDR Arria & uDR Aris (November 26, 2025)
  • K251167 — uDR Aurora CX (September 19, 2025)
  • K250788 — Definium Tempo Select (August 28, 2025)
  • K250790 — INNOVISION-DXII (August 1, 2025)
  • K250738 — YSIO X.pree (July 31, 2025)
  • K242019 — GXR-Series Diagnostic X-Ray System (January 7, 2025)
  • K242499 — Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (January 6, 2025)
  • K242119 — INNOVISION-EXII (January 3, 2025)
  • K241068 — uDR 780i (November 1, 2024)