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510(k) K232185

SM-IV by Sedecal., Sa. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2023
Date Received
July 24, 2023
Clearance Type
Special
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 Sedecal., Sa.

  • K222951 — SM-V (November 21, 2022)
  • K221803 — PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. (July 18, 2022)
  • 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)
  • K161345 — RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR (July 6, 2016)

Other clearances for product code IZL

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  • K250976 — Airbile-100 (December 19, 2025)
  • K251710 — Mobile X-ray unit (!M1) (October 24, 2025)
  • K243864 — BONX805 (September 12, 2025)
  • K251443 — PROMO (August 22, 2025)
  • K251223 — HnX-P1, HnX-PB (August 4, 2025)
  • K250597 — REMEX Xcam6 (July 31, 2025)
  • K243473 — PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS (July 29, 2025)
  • K250750 — INNOVISION-P5 (July 18, 2025)