510(k) K033316

TABLE TILT DEVICE by Brainlab AG — Product Code JAI

K033316 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "TABLE TILT DEVICE". The FDA issued a decision of Substantially Equivalent on May 14, 2004. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Brainlab AG has at least 10 other 510(k) clearances on record.