SIEMENS PACS/I-A

SIEMENS PACS/I-A is an FDA 510(k)-cleared medical device (K880690) 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 October 30, 1988. Regulation: 8.