510(k) K253670

SmartCT (R3.0 (L10)) by Philips Medical Systems B.V. — Product Code OWB

K253670 is an FDA 510(k) premarket notification submitted by Philips Medical Systems B.V. for the device "SmartCT (R3.0 (L10))". The FDA issued a decision of Substantially Equivalent on July 10, 2026. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Philips Medical Systems B.V. has at least 10 other 510(k) clearances on record.