510(k) K904044

TF-63SA by Toshiba America Medical Systems, In.C — Product Code KPW

K904044 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "TF-63SA". The FDA issued a decision of Substantially Equivalent on November 29, 1990. The device falls under product code KPW (Device, Beam Limiting, X-Ray, Diagnostic), a Class II device regulated under 21 CFR 892.1610. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.