ClearanceBrief
Company ยท US

Esaote, S.p.A.

FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.

69510(k) clearances (5 in 12 months)
9recalls (1 in 12 months)
9recalls that name a 510(k)

Product codes

CodeDeviceRecords
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic41
LNHSystem, Nuclear Magnetic Resonance Imaging29
MOSCoil, Magnetic Resonance, Specialty4
IYOSystem, Imaging, Pulsed Echo, Ultrasonic2
ITXTransducer, Ultrasonic, Diagnostic1
LLZSystem, Image Processing, Radiological1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 31, 2026K261331I-Genius (100019400)
Esaote, S.p.A., IT
LNH
Apr 6, 2026K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Esaote, S.p.A., IT
IYN
Mar 27, 2026K260746S-scan Open (100001800)
Esaote, S.p.A., IT
LNH
Mar 5, 2026K251901Magnifico Open (100009900)
Esaote, S.p.A., IT
LNH
Nov 25, 2025K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
Esaote, S.p.A., IT
IYN
Jun 18, 2025K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
Esaote, S.p.A., IT
IYN
May 16, 2025K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Esaote, S.p.A., IT
IYN
Jun 26, 2024K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)
Esaote, S.p.A., IT
LNH
Nov 29, 2023K2301796440 MyLabX90
Esaote, S.p.A., IT
IYN
Feb 4, 2022K212419Magnifico Open, Magnifico MSK
Esaote, S.p.A., IT
LNH
Sep 16, 2021K2120216430 MyLabX75, 6430 MyLab XPro75
Esaote, S.p.A., IT
IYN
Nov 22, 2019K1921576450 Ultrasound system
Esaote, S.p.A., IT
IYN
Jun 10, 2019K1910727410 Ultrasound System (MyLabSigma)
Esaote, S.p.A., IT
IYN
May 10, 2019K1909896400 Ultrasound System (MyLabX6, MyLabX7)
Esaote, S.p.A., IT
IYN
Jan 22, 2019K183685O-Scan
Esaote, S.p.A., IT
LNH
Dec 4, 2018K1831916420 Ultrasound System
Esaote, S.p.A., IT
IYN
Mar 30, 2018K180592G-scan Brio
Esaote, S.p.A., IT
LNH
Jan 12, 2018K1732916440 Ultrasound System
Esaote, S.p.A., IT
IYN
Mar 16, 2017K1630826200 Ultrasound System and 6250 Ultrasound System
Esaote, S.p.A., IT
IYN
Oct 25, 2016K161973G-scan Brio, S-scan
Esaote, S.p.A., IT
LNH
Oct 14, 2016K162290MyLabSix CrystaLine
Esaote, S.p.A., IT
IYN
Jul 19, 2016K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
Esaote, S.p.A., IT
IYN
Jul 8, 2016K161238S-scan
Esaote, S.p.A., IT
LNH
May 4, 2016K1532776200 Ultrasound System and 6250 Ultrasound System
Esaote, S.p.A., IT
IYN
Jan 8, 2016K153039MRI Dynamic Analysis Plus
Esaote, S.p.A., IT
LNH
Sep 8, 2015K151668S-scan
Esaote, S.p.A., IT
LNH
Apr 9, 2015K142421G-scan Brio
Esaote, S.p.A., IT
LNH
Sep 12, 2014K142077MYLABGAMMA
Esaote, S.p.A.
IYN
Sep 12, 2014K142008MYLABSEVEN, MYLABALPHA
Esaote, S.p.A.
IYN
Apr 25, 2014K140677MYLABSSOGNO
Esaote, S.p.A.
IYN
Apr 15, 2014K1339056200 / 6250 ULTRASOUND SYSTEM
Esaote, S.p.A.
IYN
Dec 30, 2013K133490G-SCAN BRIO
Esaote, S.p.A.
LNH
Dec 13, 2013K131996S-SCAN
Esaote, S.p.A.
LNH
Dec 4, 2013K132466MYLABSEVEN 6400, MYLABALPHA 7400
Esaote, S.p.A.
IYN
Nov 27, 2013K132231MYLABSEVEN, MYLABALPHA
Esaote, S.p.A.
IYN
Sep 19, 2012K120288ORTHOCAD SOFTWARE OPTION
Esaote, S.p.A.
LLZ
Aug 6, 2012K122006G-SCAN BRIO
Esaote, S.p.A.
LNH
Jul 9, 2012K121650S-SCAN
Esaote, S.p.A.
LNH
May 23, 2012K121384MYLABSOGNO
Esaote, S.p.A.
IYN
May 1, 2012K120748SPEEDUP SOFTWARE OPTION
Esaote, S.p.A.
LNH
Jul 22, 2011K111302MYLABSEVEN, MYLABALPHA
Esaote, S.p.A.
IYN
Jul 15, 2011K111803G-SCAN
Esaote, S.p.A.
LNH
Jun 2, 2011K110688MYLABGOLD
Esaote
IYO
Apr 8, 2011K110802A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18
Esaote, S.p.A.
LNH
Apr 6, 2011K110373TEMPOROMANIBULAR COIL 15
Esaote, S.p.A., IT
MOS
Feb 17, 2011K110238G-SCAN
Esaote, S.p.A.
LNH
Jan 7, 2011K1031526250 ULTRASOUND SYTEMS
Esaote, S.p.A.
IYN
Jun 25, 2010K100931MYLABTWICE, MODEL 6200
Esaote, S.p.A.
IYN
Apr 5, 2010K100670S-SCAN, MODEL 9800020010
Esaote, S.p.A.
MOS
Dec 23, 2009K092469O-SCAN MR SYSTEM
Esaote, S.p.A.
LNH

Newest 50 of 69.

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 3, 2026ESAOTE S.P.A.
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Completed		 ITXK230179
Sep 8, 2020ESAOTE S.P.A
AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is in
Terminated		 IYNK161359
Sep 8, 2020ESAOTE S.P.A
AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is in
Terminated		 IYNK161359
Jun 11, 2018ESAOTE S.P.A.
MyLab Seven, Model 6400
Terminated		 IYNK142008
K142077 +1
Jun 11, 2018ESAOTE S.P.A.
MyLab Gamma, Model 7410
Terminated		 IYNK142008
K142077 +1
Jun 11, 2018ESAOTE S.P.A.
MyLab Alpha, Model 7400
Terminated		 IYNK142008
K142077 +1
Jan 3, 2018ESAOTE S.P.A.
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33
Terminated		 IYNK081386
K163082
Jan 3, 2018ESAOTE S.P.A.
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
Terminated		 IYNK081386
K163082
Jul 5, 2016Esaote S.p.A.
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Terminated		 LNHK142421
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