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510(k) K192936

Soltus 500 by Sedecal., Sa. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2019
Date Received
October 18, 2019
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

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  • K202293 — Radiographic System Challenge X (October 7, 2020)
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  • 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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