ClearanceBrief
510(k) K200304 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

EPIQ Diagnostic Ultrasound System

ApplicantPhilips Ultrasound, Inc., Bothell WA, US
DecisionSubstantially Equivalent, Mar 6, 2020
ReceivedFeb 6, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K200304

DateFirm and productCodeLinked 510(k)
Aug 22, 2025Philips Ultrasound, Inc
mC12-3 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
mC7-2 Transducer Probe
Open, Classified		 IYNNone listed
Sep 21, 2021Philips Ultrasound Inc
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Terminated		 IYNNone listed

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