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)
Get daily alerts for IYNSample briefCSV

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
Decided510(k)Device and applicantCode
Jan 6, 2020K192903RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Dec 19, 2019K192410ZS3 and z.one pro Ultrasound Systems
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Dec 13, 2019K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Dec 12, 2019K192505HS50/HS60 Diagnostics Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Dec 10, 2019K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Nov 22, 2019K1921576450 Ultrasound system
Esaote, S.p.A., IT
IYN
Oct 25, 2019K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
Supersonic Imagine, FR
IYN
Oct 22, 2019K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Oct 1, 2019K192303ExactVu High Resolution Micro-Ultrasound System
Exact Imaging, Inc., CA
IYN
Sep 19, 2019K192030RS80 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Sep 18, 2019K192254InnoSight Diagnostic Ultrasound System
Qisda Corporation, TW
IYN
Sep 18, 2019K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0
Canon Medical Systems Corporation, JP
IYN
Sep 6, 2019K192226Lumify Diagnostic Ultrasound System
Philips Health Care
IYN
Aug 29, 2019K192159Voluson E6, Voluson E8, Voluson E10
GE Healthcare
IYN
Aug 29, 2019K192107Clarius Ultrasound Scanner
Clarius Mobile Health Corp., CA
IYN
Aug 15, 2019K191922ACUSON P200 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Aug 9, 2019K191798Versana Active
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Aug 9, 2019K191792Versana Balance
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Aug 9, 2019K191233ARIETTA 750
Hitachi Healthcare Americas
IYN
Jul 19, 2019K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
Canon Medical Systems Corporation, JP
IYN
Jul 10, 2019K183041Full Digital Colour Doppler Ultrasonic Diagnostic System
Wuhan Zoncare Bio-medical Electronics Co., Ltd., CN
IYN
Jun 13, 2019K190228Transcranial Doppler Ultrasound System
Shenzhen Delica Medical Equipment Co., Ltd., CN
IYN
Jun 12, 2019K191115RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 12, 2019K191055HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 10, 2019K1910727410 Ultrasound System (MyLabSigma)
Esaote, S.p.A., IT
IYN
May 22, 2019K190444HERA I10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
May 16, 2019K191023Dolphin/IQ, Dolphin/4D and Dolphin/MAX
Viasonix , Ltd., IL
IYN
May 10, 2019K190995ExactVu High Resolution Micro-Ultrasound System
Exact Imaging, Inc., CA
IYN
May 10, 2019K1909896400 Ultrasound System (MyLabX6, MyLabX7)
Esaote, S.p.A., IT
IYN
Apr 9, 2019K183660DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Apr 5, 2019K182175TCD-X
Atys, FR
IYN
Apr 4, 2019K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Apr 2, 2019K190248ARIETTA 50
Hitachi Healthcare Americas
IYN
Apr 1, 2019K1904477400 Ultrasound Systems
Navigant Consulting - on Behalf of Esaote S.P.A.
IYN
Mar 20, 2019K183575ACUSON S3000, S2000 Diagnostic Ultrasound System
Siemens Healthineers
IYN
Mar 15, 2019K190476FUJIFILM Sonosite Vevo MD Imaging System
FUJIFILM Sonosite, Inc.
IYN
Mar 8, 2019K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Mar 5, 2019K182628Imagio Ultrasound Imaging System
Seno Medical Instruments, Inc.
IYN
Feb 15, 2019K182932RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Feb 7, 2019K183235SonoSite SII Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Jan 29, 2019K182648X5 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Jan 28, 2019K183456Aloka Arietta 850
Hitachi Healthcare Americas
IYN
Jan 28, 2019K183362Venue GO
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jan 24, 2019K182594E-CUBE i7
Alpinion Medical Systems Co., Ltd., KR
IYN
Jan 22, 2019K182894HM70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jan 10, 2019K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jan 9, 2019K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jan 8, 2019K182632HS30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Dec 27, 2018K182845minisono
Alpinion Medical Systems Co., Ltd., KR
IYN
Dec 20, 2018K182165Color Doppler Ultrasound System; Model: mEye1 and mEye2
Shenzhen Well.D Medical Electronics Co., Ltd., CN
IYN

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.