510(k) K761004

X-RAY SCANNER, WHOLE BODY, AS&E by American Science and Engineering, Inc. — Product Code IZF

K761004 is an FDA 510(k) premarket notification submitted by American Science and Engineering, Inc. for the device "X-RAY SCANNER, WHOLE BODY, AS&E". The FDA issued a decision of Substantially Equivalent on December 16, 1976. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. American Science and Engineering, Inc. has at least 2 other 510(k) clearances on record.