Day

June 7, 2010
Company:GE Healthcare LLC.Date of Enforcement Report 6/2/2010 Class:ll PRODUCT 1) GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ, Cardiovascular Imaging System (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-1659-2010; 2) GE Healthcare, Innova 3100 IQ: GE Innova 3100...
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Software Risk Management

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Software Verification

IEC 62366 Usability Process and Documentation

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