MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE

MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE is an FDA 510(k)-cleared medical device (K900892) manufactured by Siemens Gammasonics, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 1990. Regulation: 8.