510(k) K190505

Low Dose Lung Screening Option by Canon Medical Systems Corporation — Product Code JAK

K190505 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Low Dose Lung Screening Option". The FDA issued a decision of Substantially Equivalent on Jun 5, 2019. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Canon Medical Systems Corporation has 96 other 510(k) clearances on record.