510(k) K992740

EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS by Imatron, Inc. — Product Code JAK

K992740 is an FDA 510(k) premarket notification submitted by Imatron, Inc. for the device "EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS". The FDA issued a decision of Substantially Equivalent on November 9, 1999. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Imatron, Inc. has at least 10 other 510(k) clearances on record.