510(k) Report

Devices descending from K171314

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+2K250120GECHONarnar, LLC20250—
+2K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+2K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+3K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+3K212012Follicle ClarityCycle Clarity20221—
+3K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+3K2013523D Auto LAAPhilips Health Care20200—
+3K200356Medo AriaMedo.Ai20203—
+3K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+3K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+4K252332FolliscanMim Fertility20260—
+4K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+4K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+4K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+4K200603AAA ModelPhilips Ultrasound, Inc.20200—
+4K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+5K262390BoneXpertVisiana20260—
+5K251417ReVISION 2Argus Cognitive, Inc.20260—
+5K250914MediAI-BACrescom Co., Ltd.20250—
+5K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+5K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+5K212376Caas QardiaPie Medical Imaging BV20220—
+5K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+6K2503303mensio WorkstationPie Medical Imaging BV202501
+6K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+6K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+6K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+6K230209Sonix HealthOntact Health Co., Ltd.20233—
+7K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+7K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+7K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+7K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+7K243684BrightHeart View ClassifierBrightheart20251—
+7K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+7K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+7K240645Sonix HealthOntact Health Co., Ltd.20240—
+8K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+8K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+8K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+8K251456BrightHeart View ClassifierBrightheart20250—
+8K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+9K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+9K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+10K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—