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FDA 510(k) Application Details - K203509
Device Classification Name
System, X-Ray, Mammographic
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510(K) Number
K203509
Device Name
System, X-Ray, Mammographic
Applicant
IMS Giotto S.p.A.
VIA Sagittario, 5
Sasso Marconi 40037 IT
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Contact
Antonella Rossi
Other 510(k) Applications for this Contact
Regulation Number
892.1710
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Classification Product Code
IZH
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More FDA Info for this Product Code
Date Received
11/30/2020
Decision Date
07/14/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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