510(k) K173639

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

K173639 is an FDA 510(k) premarket notification submitted by Siemens Medi Cal Solutions, Inc. for the device "Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax". The FDA issued a decision of Substantially Equivalent on April 2, 2018. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Siemens Medi Cal Solutions, Inc. has at least 10 other 510(k) clearances on record.