510(k) K872132

SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS by Sopha Medical Systems, Inc. — Product Code IXY

K872132 is an FDA 510(k) premarket notification submitted by Sopha Medical Systems, Inc. for the device "SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS". The FDA issued a decision of Substantially Equivalent on October 26, 1987. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Sopha Medical Systems, Inc. has at least 7 other 510(k) clearances on record.