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510(k) K212291

PHOENIX by Sedecal., Sa. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2021
Date Received
July 22, 2021
Clearance Type
Traditional
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.

  • K232185 — SM-IV (August 21, 2023)
  • K222951 — SM-V (November 21, 2022)
  • K221803 — PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. (July 18, 2022)
  • 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)

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  • 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)
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