Home / 510(k) Clearances / K161345

510(k) K161345

RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR by Sedecal., Sa. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2016
Date Received
May 13, 2016
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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