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FDA 510(k) Application Details - K203058
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K203058
Device Name
System, Image Processing, Radiological
Applicant
International Medical Solutions Inc.
2425 Matheson Blvd E
Mississauga L4W 5K4 CA
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Contact
Vernon Colaco
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
10/08/2020
Decision Date
10/29/2020
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
Y
Expedited Review
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