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FDA 510(k) Applications for Medical Device Product Code "QBS"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K220164
AZmed SAS
Rayvolve
06/02/2022
K223491
GE Medical Systems, LLC
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
05/25/2023
K212365
Gleamer
BoneView
03/01/2022
K222176
Gleamer
BoneView
03/02/2023
K193417
Imagen Technologies, Inc.
FractureDetect (FX)
07/30/2020
DEN180005
Imagen Technologies, Inc.
OsteoDetect
05/24/2018
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