510(k) K261170

BA-004CC by Fujifilm Corporation — Product Code ITX

K261170 is an FDA 510(k) premarket notification submitted by Fujifilm Corporation for the device "BA-004CC". The FDA issued a decision of Substantially Equivalent on August 12, 2026. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Fujifilm Corporation has at least 10 other 510(k) clearances on record.