510(k) K172406

Ingenuity TF by Philips Medical Systems (Cleveland), Inc. — Product Code KPS

K172406 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "Ingenuity TF". The FDA issued a decision of Substantially Equivalent on October 6, 2017. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Philips Medical Systems (Cleveland), Inc. has at least 10 other 510(k) clearances on record.