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FDA 510(k) Application Details - K191647
Device Classification Name
More FDA Info for this Device
510(K) Number
K191647
Device Name
QLAB Advanced Quantification Software
Applicant
Philips Healthcare
22100 Bothell Everett Highway
Bothell, WA 98021-8431 US
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Contact
Eri Gremi
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/20/2019
Decision Date
12/20/2019
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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