510(k) K951372

PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) by Philips Medical Systems, Inc. — Product Code IZW

K951372 is an FDA 510(k) premarket notification submitted by Philips Medical Systems, Inc. for the device "PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)". The FDA issued a decision of Substantially Equivalent on May 4, 1995. The device falls under product code IZW (Collimator, Automatic, Radiographic), a Class II device regulated under 21 CFR 892.1610. Philips Medical Systems, Inc. has at least 10 other 510(k) clearances on record.