510(k) K982171

HAMAMATSU PET SCANNER, MODEL SHR-22000 by Hamamatsu Photonics K.K. — Product Code KPS

K982171 is an FDA 510(k) premarket notification submitted by Hamamatsu Photonics K.K. for the device "HAMAMATSU PET SCANNER, MODEL SHR-22000". The FDA issued a decision of Substantially Equivalent on September 17, 1998. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Hamamatsu Photonics K.K. has at least 8 other 510(k) clearances on record.