Day

June 14, 2012
14
Jun

Warning Letter – American Optisurgical Inc.

June 14, 2012
Recipient:  American Optisurgical Inc. Product:  TX1 Tissue Removal System Date: 6/14/2012 This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act [21 U.S.C. § 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity...
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14
Jun

Cl ll Brilliance iCT and iCT SP

June 14, 2012
Company:Philips Medical Systems (Cleveland) Inc.Date of Enforcement Report 6/13/12 Class ll: PRODUCT The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and...
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IEC 29119-1 Software and System Testing

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IEC 62366 Usability Process and Documentation

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