510(k) K904146

NEURO VISION RADIOGRAPHIC X-RAY SYSTEM by Mallinckrodt Group, Inc. — Product Code KPR

K904146 is an FDA 510(k) premarket notification submitted by Mallinckrodt Group, Inc. for the device "NEURO VISION RADIOGRAPHIC X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 13, 1990. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Mallinckrodt Group, Inc. has at least 10 other 510(k) clearances on record.