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FDA 510(k) Application Details - K192317
Device Classification Name
Full Field Digital,System,X-Ray,Mammographic
More FDA Info for this Device
510(K) Number
K192317
Device Name
Full Field Digital,System,X-Ray,Mammographic
Applicant
Planmed Oy
Sorvaajankatu 7
Helsinki 00880 FI
Other 510(k) Applications for this Company
Contact
Lars Moring
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MUE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/26/2019
Decision Date
10/23/2020
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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