510(k) K001825

STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER by Standard Imaging, Inc. — Product Code JAQ

K001825 is an FDA 510(k) premarket notification submitted by Standard Imaging, Inc. for the device "STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER". The FDA issued a decision of Substantially Equivalent on August 2, 2000. 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.