ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101

ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 is an FDA 510(k)-cleared medical device (K023373) manufactured by Gvi Technology Partners. This device is classified under the Radiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 2, 2003. Regulation: 8.