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510(k) K173639

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax by Siemens Medi Cal Solutions, Inc. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2018
Date Received
November 24, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

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