
Noras Rontgen-Und Medizintechnik GmbH
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BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC is an FDA 510(k)-cleared medical device (K052987) manufactured by Noras Rontgen-Und Medizintechnik GmbH. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 7, 2005. Regulation: 8.