ClearanceBrief
510(k) K133833 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

NUVIS DIAGNOSTIC ULTRASOUND SYSTEM

ApplicantPhilips Ultrasound, Inc., Buffalo MN, US
DecisionSubstantially Equivalent, Jan 17, 2014
ReceivedDec 17, 2013
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K133833

DateFirm and productCodeLinked 510(k)
Aug 22, 2025Philips Ultrasound, Inc
C5-2 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
C5-2 Lumify Transducer Probe
Open, Classified		 IYNNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips C5-2 Transducer.
Open, Classified		 ITXNone listed

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