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

FDA 510(k) Applications for Medical Device Product Code "QFM"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K222692	Aidoc Medical, Ltd.	BriefCase	12/05/2022
K214043	Aidoc Medical, Ltd.	BriefCase	03/14/2022
K230020	Aidoc Medical, Ltd.	BriefCase	02/01/2023
K202992	Aidoc Medical, Ltd.	BriefCase, RIB Fractures Triage (RibFx)	04/14/2021
K213941	Annalise-AI	Annalise Enterprise CXR Triage Pneumothorax	02/24/2022
K222179	Annalise-AI Pty Ltd	Annalise Enterprise CXR Triage Trauma	03/28/2023
K222268	Annalise-AI Pty Ltd	Annalise Enterprise CXR Triage Trauma	03/28/2023
K191556	Behold.AI Technologies Limited	Red Dot	02/28/2020
K183285	CureMetrix, Inc	cmTriage	03/08/2019
K203517	DeepHealth, Inc.	Saige-Q	04/16/2021
K221552	Ever Fortune AI Co., Ltd.	EFAI ChestSuite XR Pneumothorax Assessment System	11/08/2022
K222076	Ever Fortune.AI Co., Ltd.	EFAI ChestSuite XR Pleural Effusion Assessment System	09/08/2022
K183182	GE Medical Systems, LLC.	Critical Care Suite	08/12/2019
K230074	iSchemaView Inc.	Rapid Aneurysm Triage and Notification	07/27/2023
K211733	Lunit Inc.	Lunit INSIGHT CXR Triage	11/10/2021
K220080	MedCognetics, Inc.	CogNet QmTRIAGE	09/29/2022
K221868	Quanta Computer Inc.	QOCA image Smart CXR Image Processing System	01/27/2023
K230899	Qure.ai Technologies	qXR-PTX-PE	08/22/2023
K193300	RADLogics, Inc.	AIMI-Triage CXR PTX	04/08/2020
K213566	Riverain Technologies, Inc.	ClearRead Xray Pneumothorax	03/10/2022
K193271	Shanghai United Imaging Intelligence Co., Ltd.	uAI EasyTriage-Rib	01/15/2021
K221241	VinBrain Joint Stock Company	DrAid for Radiology v1	09/01/2022
K223443	Viz. ai, Inc.	Viz AAA	03/17/2023
K213319	Viz.ai, Inc.	Viz ANEURYSM, Viz ANX	02/18/2022
K190362	Zebra Medical Vision Ltd.	HealthPNX	05/06/2019
K200905	Zebra Medical Vision Ltd.	HealthMammo	07/16/2020
K211803	Zebra Medical Vision Ltd.	HealthPPT	12/15/2021
K192901	Zebra Medical Vision Ltd.	HealthVCF	05/12/2020
K192320	Zebra Medical Vision, Ltd.	HealthCXR	11/26/2019