510(k) K001550

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

K001550 is an FDA 510(k) premarket notification submitted by Imatron, Inc. for the device "EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR". The FDA issued a decision of Substantially Equivalent on December 11, 2000. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Imatron, Inc. has at least 10 other 510(k) clearances on record.