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FDA 510(k) Applications Submitted by DEBORAH THOMAS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K230096
01/13/2023
Genius AI Detection 2.0 with CC-MLO Correlation
Hologic, Inc.
K201019
04/17/2020
Genius AI Detection
Hologic, Inc.
K221449
05/18/2022
Genius AI Detection 2.0
Hologic, Inc.
K111508
06/01/2011
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
HOLOGIC, INC.
K033742
11/28/2003
BOSTON SCIENTIFIC V-18 CONTROL WIRE
BOSTON SCIENTIFIC CORP.
K123873
12/17/2012
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
HOLOGIC, INC.
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