510(k) K864519

PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) by Parexel Intl. Corp. — Product Code LLZ

K864519 is an FDA 510(k) premarket notification submitted by Parexel Intl. Corp. for the device "PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)". The FDA issued a decision of Substantially Equivalent on February 13, 1987. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Parexel Intl. Corp. has at least 10 other 510(k) clearances on record.