FDA 510(k) Applications for Medical Device Product Code: QBS ()

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
K240845	AZmed SAS	Rayvolve	07/17/2024
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
K240712	icometrix NV	icobrain aria	11/07/2024
K193417	Imagen Technologies, Inc.	FractureDetect (FX)	07/30/2020
DEN180005	Imagen Technologies, Inc.	OsteoDetect	05/24/2018
K242171	Milvue	TechCare Trauma	01/17/2025