510(k) K973206

STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY by Sterling Diagnostic Imaging, Inc. — Product Code MQB

K973206 is an FDA 510(k) premarket notification submitted by Sterling Diagnostic Imaging, Inc. for the device "STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY". The FDA issued a decision of Substantially Equivalent on December 4, 1997. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Sterling Diagnostic Imaging, Inc. has at least 6 other 510(k) clearances on record.