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510(k) K203537

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems by Sedecal., Sa. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2021
Date Received
December 3, 2020
Clearance Type
Abbreviated
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

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