1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)

1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE) is an FDA 510(k)-cleared medical device (K962048) manufactured by Hitachi Medical Systems America, 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 August 13, 1996. Regulation: 8.