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FDA 510(k) Application Details - K221449
Device Classification Name
More FDA Info for this Device
510(K) Number
K221449
Device Name
Genius AI Detection 2.0
Applicant
Hologic, Inc.
250 Campus Drive
Marlborough, MA 01730 US
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Contact
Deborah Thomas
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Regulation Number
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Classification Product Code
QDQ
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Date Received
05/18/2022
Decision Date
10/06/2022
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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