Day

May 11, 2005
11
May

Inc. Class II Siemens Medical Solutions USA

May 11, 2005
Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 5/11/05 Class: II PRODUCT Axiom Artis X-Ray System using software version VB11D or VB20B. Recall # Z-0796-05. CODE Model numbers 5904433, 5904441, 5904466, 7007755, 7008605, 7412807, 7413078, 7555365, 7555373, 7727717, and 7728350. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated...
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11
May

CBER Software Submission Guidance. New FDA CDRH

May 11, 2005
/docs/FDASoftwareSubmissionGuidance.pdf
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11
May

CBER Software Submission Guidance FDA CDRH

May 11, 2005
/docs/FDASoftwareSubmissionGuidance.pdf
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