ClearanceBrief
Company ยท US

Philips Ultrasound, Inc

FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2026. Name variants (Inc, Corp, punctuation) are merged.

78510(k) clearances (9 in 12 months)
141recalls (15 in 12 months)
141recalls that name a 510(k)

Product codes

CodeDeviceRecords
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic145
ITXTransducer, Ultrasonic, Diagnostic42
LLZSystem, Image Processing, Radiological18
IYOSystem, Imaging, Pulsed Echo, Ultrasonic5
JAKSystem, X-Ray, Tomography, Computed3
DPWFlowmeter, Blood, Cardiovascular1
HGLTransducer, Ultrasonic, Obstetric1
JOPTransducer, Ultrasonic1
KPRSystem, X-Ray, Stationary1
QIHAutomated Radiological Image Processing Software1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 25, 2026K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Aug 4, 2026K262311Alturion Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Jul 27, 2026K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Jun 29, 2026K260667Alturion Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
May 27, 2026K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
IYN
May 27, 2026K260123EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
May 5, 2026K252558Lumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Mar 27, 2026K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Dec 22, 2025K252557Lumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Oct 9, 2025K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Jul 24, 2025K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Jun 18, 2025K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
IYN
May 21, 2025K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
May 15, 2025K242519Lumify Diagnostic Ultrasound System
Philips Ultrasound
IYN
May 9, 2025K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
IYN
May 8, 2025K242670Lumify Diagnostic Ultrasound System
Philips Ultrasound
IYN
Apr 28, 2025K250030Flash Ultrasound System 5100 Point of Care
Philips Ultrasound, LLC
IYN
Apr 10, 2025K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Feb 10, 2025K241659Ultrasound Workspace (UWS 6.0)
Philips Ultrasound, LLC
QIH
Feb 6, 2025K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Dec 12, 2024K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Nov 15, 2024K242800The 5000 Compact Series Ultrasound Systems
Philips Ultrasound, LLC
IYN
Oct 7, 2024K240980EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Apr 24, 2024K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
IYN
Feb 13, 2024K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Nov 30, 2023K233545EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Oct 26, 2023K232500Lumify Diagnostic Ultrasound System
Philips Ultrasound
IYN
May 12, 2023K231190EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
May 4, 2023K223771Lumify Diagnostic Ultrasound System
Philips Ultrasound
IYN
Jan 18, 2023K223804PercuNav Image Fusion and Interventional Navigation System
Philips Ultrasound, LLC
JAK
Sep 27, 2022K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ul
Philips Ultrasound, LLC
IYN
Sep 24, 2021K212777Collaboration Live
Philips Ultrasound, Inc.
LLZ
Feb 23, 2021K203406Lumify Diagnostic Ultrasound System
Philips Ultrasound, Inc.
IYN
Sep 20, 2020K200603AAA Model
Philips Ultrasound, Inc.
LLZ
Sep 15, 2020K201665Collaboration Live
Philips Ultrasound, Inc.
LLZ
Sep 2, 2020K202216EPIQ Series Diagnostic Ultrasound Systems
Philips Ultrasound, Inc.
IYN
May 14, 2020K201053PercuNav Image Fusion and Interventional Navigation
Philips Ultrasound, Inc.
JAK
May 1, 2020K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound Syste
Philips Ultrasound, Inc.
IYN
Mar 6, 2020K200304EPIQ Diagnostic Ultrasound System
Philips Ultrasound, Inc.
IYN
Nov 9, 2018K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30
Philips Ultrasound, Inc.
IYN
Oct 23, 2018K182529Xperius Ultrasound System
Philips Ultrasound, Inc.
IYN
Jul 27, 2018K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System
Philips Ultrasound, Inc.
IYN
Jun 7, 2018K181264QLAB Advanced Quantification Software
Philips Ultrasound, Inc.
LLZ
Apr 21, 2017K170716PercuNav Image Fusion and Interventional Navigation
Philips Ultrasound, Inc.
JAK
Jan 10, 2017K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affi
Philips Ultrasound, Inc.
IYN
Apr 6, 2016K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affin
Philips Ultrasound, Inc.
IYN
Jul 2, 2014K141369VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM
Philips Ultrasound, Inc.
IYN
Apr 17, 2014K140808Q-STATION
Philips Ultrasound, Inc.
LLZ
Jan 17, 2014K133833NUVIS DIAGNOSTIC ULTRASOUND SYSTEM
Philips Ultrasound, Inc.
IYN
Aug 21, 2013K132304EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Philips Ultrasound, Inc.
IYN

Newest 50 of 78.

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 16, 2026Philips Ultrasound, LLC
Philips Lumify Diagnostic Ultrasound System
Open, Classified		 IYNK242519
K242670
Sep 18, 2026Philips Ultrasound, LLC
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Open, Classified		 IYNK260123
K260680
Mar 24, 2026Philips Ultrasound, Inc
Philips X7-2 Ultrasound Transducer
Open, Classified		 ITXK160807
K163120 +3
Mar 24, 2026Philips Ultrasound, Inc
Philips X3-1 Ultrasound Transducer
Open, Classified		 ITXK042540
Mar 24, 2026Philips Ultrasound, Inc
Philips S5-2 Ultrasound Transducer
Open, Classified		 ITXK081661
Mar 24, 2026Philips Ultrasound, Inc
Philips S4-1 Ultrasound Transducer
Open, Classified		 ITXK030455
K120321 +3
Mar 24, 2026Philips Ultrasound, Inc
Philips OMNI III TEE Ultrasound Transducer
Open, Classified		 ITXK043535
K081661
Mar 24, 2026Philips Ultrasound, Inc
Philips OMNI II TEE Ultrasound Transducer
Open, Classified		 ITXK014191
Mar 24, 2026Philips Ultrasound, Inc
Philips Mini Multi TEE Ultrasound Transducer
Open, Classified		 ITXK043535
K132304 +3
Mar 24, 2026Philips Ultrasound, Inc
Philips L17-5 Ultrasound Transducer
Open, Classified		 ITXK030455
Mar 24, 2026Philips Ultrasound, Inc
Philips L12-5 Ultrasound Transducer
Open, Classified		 ITXK030455
K043535 +3
Mar 24, 2026Philips Ultrasound, Inc
Philips C9-4 Ultrasound Transducer
Open, Classified		 ITXK030455
K043535
Mar 24, 2026Philips Ultrasound, Inc
Philips 3D6-2 Ultrasound Transducer
Open, Classified		 ITXK034003
K043535
Dec 31, 2025Philips Ultrasound, LLC
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Completed		 IYNK231190
Dec 4, 2025Philips Ultrasound, LLC
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Open, Classified		 IYNK203406
K223771 +3
Aug 22, 2025Philips Ultrasound, Inc
XL14-3 Transducer Probe
Open, Classified		 IYNK172607
K181485 +3
Aug 22, 2025Philips Ultrasound, Inc
X8-2t Transducer Probe
Open, Classified		 IYNK163120
K172607 +3
Aug 22, 2025Philips Ultrasound, Inc
X7-2t Transducer Probe
Open, Classified		 IYNK081802
K111513 +3
Aug 22, 2025Philips Ultrasound, Inc
X7-2 Transducer Probe
Open, Classified		 IYNK160807
K163120 +3
Aug 22, 2025Philips Ultrasound, Inc
X6-1 Transducer Probe
Open, Classified		 IYNK132304
K160807 +3
Aug 22, 2025Philips Ultrasound, Inc
X5-1c Transducer Probe
Open, Classified		 IYNK233788
Aug 22, 2025Philips Ultrasound, Inc
X5-1 Transducer Probe
Open, Classified		 IYNK132304
K160807 +3
Aug 22, 2025Philips Ultrasound, Inc
X3-1 Transducer Probe
Open, Classified		 IYNK042540
Aug 22, 2025Philips Ultrasound, Inc
X11-4t Transducer Probe
Open, Classified		 IYNK233545
Aug 22, 2025Philips Ultrasound, Inc
VL13-5 Transducer Probe
Open, Classified		 IYNK160807
K163120 +3
Aug 22, 2025Philips Ultrasound, Inc
V9-2 Transducer Probe
Open, Classified		 IYNK182857
K202216
Aug 22, 2025Philips Ultrasound, Inc
V6-2 Transducer Probe
Open, Classified		 IYNK062247
K081661 +3
Aug 22, 2025Philips Ultrasound, Inc
TRANSDUCER L12-5 Transducer Probe
Open, Classified		 IYNK030455
K132304 +3
Aug 22, 2025Philips Ultrasound, Inc
Transducer C10-3v Transducer Probe
Open, Classified		 IYNK123754
Aug 22, 2025Philips Ultrasound, Inc
SCNHD LA L7-4 HDI Transducer Probe
Open, Classified		 ITXK014182
Aug 22, 2025Philips Ultrasound, Inc
S9-2 Transducer Probe
Open, Classified		 IYNK181485
K182857
Aug 22, 2025Philips Ultrasound, Inc
S8-3t Transducer Probe
Open, Classified		 IYNK172607
K181485 +2
Aug 22, 2025Philips Ultrasound, Inc
S8-3 Transducer Probe
Open, Classified		 IYNK043535
K081661 +3
Aug 22, 2025Philips Ultrasound, Inc
S7-2t Transducer Probe
Open, Classified		 IYNK043535
K081661
Aug 22, 2025Philips Ultrasound, Inc
S7-3t Transducer Probe
Open, Classified		 IYNK043535
K132304 +3
Aug 22, 2025Philips Ultrasound, Inc
S5-2 Transducer Probe
Open, Classified		 IYNK081661
Aug 22, 2025Philips Ultrasound, Inc
S4-2 Transducer Probe
Open, Classified		 IYNK043535
K160807 +3
Aug 22, 2025Philips Ultrasound, Inc
S4-1 Lumify Transducer Probe
Open, Classified		 IYNK162549
K192226 +3
Aug 22, 2025Philips Ultrasound, Inc
S4-1 Transducer Probe
Open, Classified		 IYNK030455
K120321 +3
Aug 22, 2025Philips Ultrasound, Inc
S3-1 Transducer Probe
Open, Classified		 IYNK030455
K043535
Aug 22, 2025Philips Ultrasound, Inc
S12-4 Transducer Probe
Open, Classified		 IYNK043535
K123754 +3
Aug 22, 2025Philips Ultrasound, Inc
OMNI III TEE Transducer Probe
Open, Classified		 IYNK014191
K954028
Aug 22, 2025Philips Ultrasound, Inc
OMNI II TEE Transducer Probe
Open, Classified		 IYNK014191
K954028
Aug 22, 2025Philips Ultrasound, Inc
mL26-8 Transducer Probe
Open, Classified		 IYNK231190
K250030
Aug 22, 2025Philips Ultrasound, Inc
Mini Multi TEE Transducer Probe
Open, Classified		 IYNK043535
K132304 +3
Aug 22, 2025Philips Ultrasound, Inc
mC7-2 Transducer Probe
Open, Classified		 IYNK200304
Aug 22, 2025Philips Ultrasound, Inc
mC12-3 Transducer Probe
Open, Classified		 IYNK200304
Aug 22, 2025Philips Ultrasound, Inc
L9-3 Transducer Probe
Open, Classified		 IYNK030455
Aug 22, 2025Philips Ultrasound, Inc
L8-4 Transducer Probe
Open, Classified		 IYNK030455
K043535
Aug 22, 2025Philips Ultrasound, Inc
L18-5 Transducer Probe
Open, Classified		 IYNK132304
K160807 +3

Newest 50 of 141.

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