ClearanceBrief
510(k) K160807 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

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

ApplicantPhilips Ultrasound, Inc., Andover MA, US
DecisionSubstantially Equivalent, Apr 6, 2016
ReceivedMar 24, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K160807

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
3D9-3v Transducer Probe
Open, Classified		 IYNNone 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
L12-4 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
S12-4 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
S8-3 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
V6-2 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
X7-2t 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 L12-4 Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips S7-3t Transducer.
Open, Classified		 ITXNone listed
Jul 2, 2025Philips Ultrasound, Inc
Philips V6-2 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 X7-2t Transducer.
Open, Classified		 ITXNone listed
Aug 30, 2019Philips Ultrasound Inc
Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow a
Terminated		 ITXNone listed

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