510(k) Report

Devices descending from K191647

41 later devices reach QLAB Advanced Quantification Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212012Follicle ClarityCycle Clarity20221—
+1K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+1K2013523D Auto LAAPhilips Health Care20200—
+1K200356Medo AriaMedo.Ai20203—
+1K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+1K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+2K252332FolliscanMim Fertility20260—
+2K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+2K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+2K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+2K200603AAA ModelPhilips Ultrasound, Inc.20200—
+2K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+3K262390BoneXpertVisiana20260—
+3K251417ReVISION 2Argus Cognitive, Inc.20260—
+3K250914MediAI-BACrescom Co., Ltd.20250—
+3K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+3K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+3K212376Caas QardiaPie Medical Imaging BV20220—
+3K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+4K2503303mensio WorkstationPie Medical Imaging BV202501
+4K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+4K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+4K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+4K230209Sonix HealthOntact Health Co., Ltd.20233—
+5K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+5K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+5K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+5K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+5K243684BrightHeart View ClassifierBrightheart20251—
+5K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+5K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+5K240645Sonix HealthOntact Health Co., Ltd.20240—
+6K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+6K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+6K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+6K251456BrightHeart View ClassifierBrightheart20250—
+6K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+7K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+7K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+7K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+8K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—