510(k) K254090

I-View® by Hologic, Inc. — Product Code MUE

K254090 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "I-View®". The FDA issued a decision of Substantially Equivalent on September 2, 2026. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. Hologic, Inc. has at least 10 other 510(k) clearances on record.