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FDA 510(k) Application Details - K211655
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K211655
Device Name
System, Image Processing, Radiological
Applicant
EXINI Diagnostics AB
Ideon Science Park, ScheelevΣgen 27
Lund SE-223 70 SE
Other 510(k) Applications for this Company
Contact
Aseem Anand
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
05/28/2021
Decision Date
07/27/2021
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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