ClearanceBrief
Panels › Radiology › Product code IYN · Class 2

System, Imaging, Pulsed Doppler, Ultrasonic

Regulation 892.1550

56510(k)s in 12 months (1,189 all time)
10recalls in 12 months (300 all time)
288recalls that name a 510(k)
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Top companies in IYN

Company510(k)sRecalls
Philips Ultrasound5293
Siemens Medical Solutions USA, Inc.7562
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.850
Samsung Medison Co., Ltd.700
GE Healthcare5215
GE Medical Systems Ultrasound and Primary Care Diagnostics620
Esaote, S.p.A.347
Alpinion Medical Systems Co., Ltd.250
FUJIFILM Sonosite, Inc.250
General Electric Co.230
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
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
Nov 6, 2025B-K Medical A/S
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
Open, Classified		 IYNK223830
Nov 6, 2025B-K Medical A/S
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
Open, Classified		 IYNK223830
Nov 6, 2025B-K Medical A/S
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
Open, Classified		 IYNK223830
Nov 6, 2025B-K Medical A/S
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
Open, Classified		 IYNK223830
Nov 6, 2025B-K Medical A/S
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
Open, Classified		 IYNK231764
Nov 6, 2025B-K Medical A/S
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed D
Open, Classified		 IYNK132335
Oct 15, 2025GE Medical Systems, LLC
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Open, Classified		 IYNK214039
Oct 15, 2025GE Medical Systems, LLC
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Open, Classified		 IYNK214039
Oct 15, 2025GE Medical Systems, LLC
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
Open, Classified		 IYNK214039
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
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
Aug 22, 2025Philips Ultrasound, Inc
L17-5 Transducer Probe
Open, Classified		 IYNK030455
Aug 22, 2025Philips Ultrasound, Inc
L15-7IO TRANSDUCER Transducer Probe
Open, Classified		 IYNK030455
K043535 +3
Aug 22, 2025Philips Ultrasound, Inc
L15-7io Transducer Probe
Open, Classified		 IYNK030455
K043535 +3

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