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Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc
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GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X is an FDA 510(k)-cleared medical device (K032656) manufactured by Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc. 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 29, 2003. Regulation: 8.