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SIEMENS 510O(K) SUMMARY AR0221 FOR
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Document Date: 2013-05-06 11:19:40

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File Size: 203,07 KB

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City

Stream Parkway Malvern / Malvern / /

Company

Class 11 90JAK Siemens Medical Solutions Inc. / In Vitro Diagnostics / Siemens Medical Solutions Inc. / Siemens Medical Solutions USA Inc. / K123541 Trade / Usability Siemens Medical Solutions Inc. / Regulatory Affairs Submissions Siemens Medical Solutions Inc. / /

Country

United States / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

/

IndustryTerm

software processes images / extraction product / announcements concerning your device / predicate devices / flow extraction product / predicate device / manufacturing practice requirements / contrast media / software specifications / post processing software package / simultaneous multi-slice processing / risk management / manufacturing practice / electrical equipment / software package / imaging / Internet address http /

MedicalCondition

acute ischemnic stroke / stroke / acute stroke / brain tumors / /

NaturalFeature

Valley Stream Parkway / /

Organization

Radiological Health Office / Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / FDA / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Radiological Health Center for Devices and Radiological Health Indications for Use / CDRH's office of Surveillance / /

Person

Silver Spring / Janine M. Morris / Kimberly Mangum / /

/

Position

Director / Division / General / Technical Specialist / /

Product

Federal Food / K073238 / 2I1CFR / /

ProvinceOrState

Pennsylvania / Maryland / /

Technology

radiation / X-ray System / Tomography / Digital Imaging / /

URL

www.fda.gov/AboutFDA/CentersOffices/CbRH/CDF-HOffices/ucm / http /

SocialTag