510(k) K973833

CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL by Dynarad Corp. — Product Code IZL

K973833 is an FDA 510(k) premarket notification submitted by Dynarad Corp. for the device "CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL". The FDA issued a decision of Substantially Equivalent on December 30, 1997. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Dynarad Corp. has at least 8 other 510(k) clearances on record.