510(k) K182537

RADMAX Digital Imaging Software by DRGEM Corporation — Product Code LLZ

K182537 is an FDA 510(k) premarket notification submitted by DRGEM Corporation for the device "RADMAX Digital Imaging Software". The FDA issued a decision of Substantially Equivalent on March 8, 2019. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. DRGEM Corporation has at least 10 other 510(k) clearances on record.