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510(k) K090279

SEDECAL, MILLENNIUM PLUS by Sedecal., Sa. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2009
Date Received
February 4, 2009
Clearance Type
Special
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 Sedecal., Sa.

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  • K212291 — PHOENIX (September 14, 2021)
  • K203537 — Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems (February 1, 2021)
  • K202293 — Radiographic System Challenge X (October 7, 2020)
  • K192936 — Soltus 500 (November 15, 2019)
  • K192011 — PhoeniX (September 25, 2019)
  • K191813 — MobileDiagnost wDR 2.2 (August 2, 2019)
  • K173299 — DRAGON X SPSL4HC, DRAGON X SPSL8HC (January 26, 2018)

Other clearances for product code KPR

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  • 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)