510(k) K760201

X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC by American Science and Engineering, Inc. — Product Code JAK

K760201 is an FDA 510(k) premarket notification submitted by American Science and Engineering, Inc. for the device "X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC". The FDA issued a decision of Substantially Equivalent on October 5, 1976. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. American Science and Engineering, Inc. has at least 2 other 510(k) clearances on record.