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FDA 510(k) Application Details - K131873
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K131873
Device Name
System, Image Processing, Radiological
Applicant
METHODSENSE, INC.
P.O. BOX 110352
DURHAM, NC 27709 US
Other 510(k) Applications for this Company
Contact
RITA KING
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
06/24/2013
Decision Date
09/25/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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