
Optimal Imaging Systems, Inc.
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OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K000034) manufactured by Optimal Imaging Systems, 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 February 23, 2000. Regulation: 8.