510(k) K970640

PHILIPS EASY DIAGNOST by Philips Medical Systems North America, Inc. — Product Code IXR

K970640 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America, Inc. for the device "PHILIPS EASY DIAGNOST". The FDA issued a decision of Substantially Equivalent on March 21, 1997. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Philips Medical Systems North America, Inc. has at least 10 other 510(k) clearances on record.