ClearanceBrief
510(k) K172607 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

ApplicantPhilips Health Care, Bothell WA, US
DecisionSubstantially Equivalent, Oct 4, 2017
ReceivedAug 30, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K172607

DateFirm and productCodeLinked 510(k)
Mar 24, 2026Philips Ultrasound, Inc
Philips Mini Multi TEE Ultrasound Transducer
Open, Classified		 ITXNone listed
Mar 24, 2026Philips Ultrasound, Inc
Philips X7-2 Ultrasound Transducer
Open, Classified		 ITXNone listed
Aug 22, 2025Philips Ultrasound, Inc
BP10-5ec Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
C10-3v Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
C10-4ec Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
C6-2 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
C9-2 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
C9-4v Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
D2TCD Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
L18-5 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
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
S8-3t Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
TRANSDUCER L12-5 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
VL13-5 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
X5-1 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
X6-1 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
X7-2 Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
X8-2t Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
XL14-3 Transducer Probe
Open, Classified		 IYNNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips eL18-4 Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips eL18-4 EMT Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips S7-3t Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips S8-3t Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips VL13-5 Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips X5-1 Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips X6-1 Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips X8-2t Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips XL14-3 Transducer.
Open, Classified		 ITXNone listed
Aug 30, 2019Philips Ultrasound Inc
Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fl
Terminated		 ITXNone listed

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