510(k) K950883

POLYDOROS SX 65 AND 80 by Siemens Medical Solutions USA, Inc. — Product Code IZO

K950883 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "POLYDOROS SX 65 AND 80". The FDA issued a decision of Substantially Equivalent on April 3, 1995. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.