510(k) K983678

ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE by Elekta Instruments, Inc. — Product Code JAI

K983678 is an FDA 510(k) premarket notification submitted by Elekta Instruments, Inc. for the device "ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE". The FDA issued a decision of Substantially Equivalent on January 15, 1999. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Elekta Instruments, Inc. has at least 7 other 510(k) clearances on record.