510(k) K902637

FUTURUS 2001 X-RAY GENERATOR by Acoma Medical Imaging, Inc. — Product Code IZO

K902637 is an FDA 510(k) premarket notification submitted by Acoma Medical Imaging, Inc. for the device "FUTURUS 2001 X-RAY GENERATOR". The FDA issued a decision of Substantially Equivalent on August 3, 1990. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Acoma Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.