ClearanceBrief
510(k) K043535 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

HD11 DIAGNOSTIC ULTRASOUND SYSTEM

ApplicantPhilips Ultrasound, Inc., Andover MA, US
DecisionSubstantially Equivalent, Jan 6, 2005
ReceivedDec 22, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K043535

DateFirm and productCodeLinked 510(k)
Mar 24, 2026Philips Ultrasound, Inc
Philips 3D6-2 Ultrasound Transducer
Open, Classified		 ITXNone listed
Mar 24, 2026Philips Ultrasound, Inc
Philips C9-4 Ultrasound Transducer
Open, Classified		 ITXNone listed
Mar 24, 2026Philips Ultrasound, Inc
Philips L12-5 Ultrasound Transducer
Open, Classified		 ITXNone listed
Mar 24, 2026Philips Ultrasound, Inc
Philips Mini Multi TEE Ultrasound Transducer
Open, Classified		 ITXNone listed
Mar 24, 2026Philips Ultrasound, Inc
Philips OMNI III TEE Ultrasound Transducer
Open, Classified		 ITXNone listed
Aug 22, 2025Philips Ultrasound, Inc
3D6-2 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
3D9-3v Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
C5-2 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
C8-4v Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
C8-4v Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
C8-5 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
C9-4 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
C9-5ec Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
D5cwc Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
L12-3 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
L12-5 50 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
L15-7io Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
L15-7IO TRANSDUCER Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
L8-4 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
Mini Multi TEE Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
S12-4 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
S3-1 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
S4-2 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
S7-3t Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
S7-2t Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
S8-3 Transducer Probe
Open, Classified		 IYNNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips 3D9-3v Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips C5-2 Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips C9-5EC Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips L12-3 Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips L8-4 Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips S7-2 Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips S7-3t Transducer.
Open, Classified		 ITXNone listed
Sep 6, 2023Philips Ultrasound, Inc.
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Completed		 ITXNone listed
Aug 30, 2019Philips Ultrasound Inc
Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body
Terminated		 ITXNone listed
Jul 3, 2007Philips Medical Systems
HD11XE Diagnostic Ultrasound System
Terminated		 IYNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.