510(k) K060532

HDR 1000 PLUS WELL CHAMBER, MODEL 90008 by Standard Imaging, Inc. — Product Code JAQ

K060532 is an FDA 510(k) premarket notification submitted by Standard Imaging, Inc. for the device "HDR 1000 PLUS WELL CHAMBER, MODEL 90008". The FDA issued a decision of Substantially Equivalent on April 11, 2006. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Standard Imaging, Inc. has at least 9 other 510(k) clearances on record.