ClearanceBrief
510(k) K034003 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM

ApplicantPhilips Ultrasound, Inc., Bothell WA, US
DecisionSubstantially Equivalent, Jan 8, 2004
ReceivedDec 24, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K034003

DateFirm and productCodeLinked 510(k)
Mar 24, 2026Philips Ultrasound, Inc
Philips 3D6-2 Ultrasound Transducer
Open, Classified		 ITXNone listed
Aug 22, 2025Philips Ultrasound, Inc
3D6-2 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

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