ClearanceBrief
Panels › Radiology › Product code IYN · Class 2

System, Imaging, Pulsed Doppler, Ultrasonic

Regulation 892.1550

55510(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)
Aug 22, 2025Philips Ultrasound, Inc
L12-5 50 Transducer Probe
Open, Classified		 IYNK030455
K043535 +3
Aug 22, 2025Philips Ultrasound, Inc
L12-5 38mm Transducer Probe
Open, Classified		 IYNK153480
Aug 22, 2025Philips Ultrasound, Inc
L12-4 Lumify Transducer Probe
Open, Classified		 IYNK152899
K162549 +3
Aug 22, 2025Philips Ultrasound, Inc
L12-4 Transducer Probe
Open, Classified		 IYNK120321
K152899 +3
Aug 22, 2025Philips Ultrasound, Inc
L12-3 Transducer Probe
Open, Classified		 IYNK043535
K081661 +3
Aug 22, 2025Philips Ultrasound, Inc
L11-3 Transducer Probe
Open, Classified		 IYNK030455
Aug 22, 2025Philips Ultrasound, Inc
L10-4LAP Transducer Probe
Open, Classified		 IYNK123754
K162329
Aug 22, 2025Philips Ultrasound, Inc
eL18-4 Transducer Probe
Open, Classified		 IYNK123754
K181485 +3
Aug 22, 2025Philips Ultrasound, Inc
D5cwc Transducer Probe
Open, Classified		 IYNK030455
K043535 +3
Aug 22, 2025Philips Ultrasound, Inc
D2TCD Transducer Probe
Open, Classified		 IYNK030455
K132304 +3
Aug 22, 2025Philips Ultrasound, Inc
D2cwc Transducer Probe
Open, Classified		 IYNK030455
K081661 +3
Aug 22, 2025Philips Ultrasound, Inc
C9-5ec Transducer Probe
Open, Classified		 IYNK030455
K043535
Aug 22, 2025Philips Ultrasound, Inc
C9-4v Transducer Probe
Open, Classified		 IYNK120321
K153480 +3
Aug 22, 2025Philips Ultrasound, Inc
C9-4 Transducer Probe
Open, Classified		 IYNK030455
K043535
Aug 22, 2025Philips Ultrasound, Inc
C9-3v Transducer Probe
Open, Classified		 IYNK091804
K111513 +1
Aug 22, 2025Philips Ultrasound, Inc
C9-3io Transducer Probe
Open, Classified		 IYNK123754
K162329
Aug 22, 2025Philips Ultrasound, Inc
C9-2 Transducer Probe
Open, Classified		 IYNK132304
K160807 +3
Aug 22, 2025Philips Ultrasound, Inc
C8-5 Transducer Probe
Open, Classified		 IYNK030455
K043535 +3
Aug 22, 2025Philips Ultrasound, Inc
C8-4v Transducer Probe
Open, Classified		 IYNK030455
K034003 +2
Aug 22, 2025Philips Ultrasound, Inc
C8-4v Transducer Probe
Open, Classified		 IYNK030455
K034003 +2
Aug 22, 2025Philips Ultrasound, Inc
C6-3 Transducer Probe
Open, Classified		 IYNK062247
K081661
Aug 22, 2025Philips Ultrasound, Inc
C6-2 Transducer Probe
Open, Classified		 IYNK160807
K163120 +3
Aug 22, 2025Philips Ultrasound, Inc
C5-2 Lumify Transducer Probe
Open, Classified		 IYNK133833
K152899 +3
Aug 22, 2025Philips Ultrasound, Inc
C5-2 Transducer Probe
Open, Classified		 IYNK030455
K043535 +3
Aug 22, 2025Philips Ultrasound, Inc
c5-1 Transducer Probe
Open, Classified		 IYNK091804
K111513 +3
Aug 22, 2025Philips Ultrasound, Inc
C10-4ec Transducer Probe
Open, Classified		 IYNK132304
K160807 +3
Aug 22, 2025Philips Ultrasound, Inc
C10-3v Transducer Probe
Open, Classified		 IYNK123754
K132304 +3
Aug 22, 2025Philips Ultrasound, Inc
BP10-5ec Transducer Probe
Open, Classified		 IYNK081661
K160807 +3
Aug 22, 2025Philips Ultrasound, Inc
3D9-3v Transducer Probe
Open, Classified		 IYNK043535
K081661 +3
Aug 22, 2025Philips Ultrasound, Inc
3D6-2 Transducer Probe
Open, Classified		 IYNK034003
K043535
Jun 26, 2025GE Medical Systems China Co., Ltd.
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog N
Open, Classified		 IYNK242005
Jun 26, 2025GE Medical Systems China Co., Ltd.
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Open, Classified		 IYNK242005
Apr 11, 2025GE Medical Systems, LLC
Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for Chin
Open, Classified		 IYNK203137
K220848 +1
Apr 11, 2025GE Medical Systems, LLC
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP f
Open, Classified		 IYNK183362
K202233 +2
Oct 18, 2024B-K Medical A/S
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
Open, Classified		 IYNK223830
Sep 24, 2024Siemens Medical Solutions USA, Inc.
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
Open, Classified		 IYNK232617
Sep 24, 2024Siemens Medical Solutions USA, Inc.
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Open, Classified		 IYNK210743
Sep 24, 2024Siemens Medical Solutions USA, Inc.
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
Open, Classified		 IYNK201130
Jul 10, 2024Echonous Inc
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
Open, Classified		 IYNK212100
Jul 5, 2024GE Vingmed Ultrasound As
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
Open, Classified		 IYNK142323
Jul 5, 2024GE Vingmed Ultrasound As
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
Open, Classified		 IYNK150087
Jun 27, 2024NovaSignal Corp.
NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Open, Classified		 IYNK213279
Jun 27, 2024NovaSignal Corp.
NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Open, Classified		 IYNK213279
May 22, 2024FUJIFILM Healthcare Americas Corporation
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
Open, Classified		 IYNK160559
May 3, 2024Philips Ultrasound, Inc.
5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Pre
Open, Classified		 IYNK222648
Apr 19, 2024Siemens Medical Solutions USA, Inc.
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Open, Classified		 IYNK232617
Apr 19, 2024Siemens Medical Solutions USA, Inc.
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
Open, Classified		 IYNK210743
Apr 19, 2024Siemens Medical Solutions USA, Inc.
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB1
Open, Classified		 IYNK201130
Jan 30, 2024GE HEALTHCARE AUSTRIA GMBH & CO
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Open, Classified		 IYNK160184
Jan 25, 2024B-K Medical A/S
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Open, Classified		 IYNK223830

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