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FDA 510(k) Application Details - K111245
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K111245
Device Name
System, Image Processing, Radiological
Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
22100 BOTHELL EVERETT HIGHWAY
BOTHELL, WA 98021-8431 US
Other 510(k) Applications for this Company
Contact
LYNN HARMER
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/03/2011
Decision Date
07/29/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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