Medical Device Manufacturer · IT , Genoa

Esaote, S.P.A.

65 submissions · 65 cleared · Since 2003
65
Total
65
Cleared
0
Denied

Esaote, S.P.A. — FDA 510(k) Submissions

Esaote, S.P.A. has submitted 65 FDA 510(k) premarket notifications since 2003, of which 65 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Imaging, Pulsed Doppler, Ultrasonic, System, Nuclear Magnetic Resonance Imaging, Coil, Magnetic Resonance, Specialty, System, Imaging, Pulsed Echo, Ultrasonic, System, Image Processing, Radiological . Use the specialty filter in the sidebar to narrow results.

65 devices
1–25 of 65
Magnifico Open (100009900)
K251901 · LNH System, Nuclear Magnetic... · Radiology
Mar 2026 258d
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
K253310 · IYN System, Imaging, Pulsed... · Radiology
Nov 2025 57d
6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
K243253 · IYN System, Imaging, Pulsed... · Radiology
Jun 2025 246d
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
K241671 · IYN System, Imaging, Pulsed... · Radiology
May 2025 339d
Magnifico Open (100009900); Magnifico MSK ( 100009910)
K241133 · LNH System, Nuclear Magnetic... · Radiology
Jun 2024 63d
6440 MyLabX90
K230179 · IYN System, Imaging, Pulsed... · Radiology
Nov 2023 310d
Magnifico Open, Magnifico MSK
K212419 · LNH System, Nuclear Magnetic... · Radiology
Feb 2022 184d
6430 MyLabX75, 6430 MyLab XPro75
K212021 · IYN System, Imaging, Pulsed... · Radiology
Sep 2021 80d
6450 Ultrasound system
K192157 · IYN System, Imaging, Pulsed... · Radiology
Nov 2019 105d
7410 Ultrasound System (MyLabSigma)
K191072 · IYN System, Imaging, Pulsed... · Radiology
Jun 2019 49d
6400 Ultrasound System (MyLabX6, MyLabX7)
K190989 · IYN System, Imaging, Pulsed... · Radiology
May 2019 25d
O-Scan
K183685 · LNH System, Nuclear Magnetic... · Radiology
Jan 2019 25d
6420 Ultrasound System
K183191 · IYN System, Imaging, Pulsed... · Radiology
Dec 2018 15d
G-scan Brio
K180592 · LNH System, Nuclear Magnetic... · Radiology
Mar 2018 24d
6440 Ultrasound System
K173291 · IYN System, Imaging, Pulsed... · Radiology
Jan 2018 88d
6200 Ultrasound System and 6250 Ultrasound System
K163082 · IYN System, Imaging, Pulsed... · Radiology
Mar 2017 133d
G-scan Brio, S-scan
K161973 · LNH System, Nuclear Magnetic... · Radiology
Oct 2016 99d
MyLabSix CrystaLine
K162290 · IYN System, Imaging, Pulsed... · Radiology
Oct 2016 60d
6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
K161359 · IYN System, Imaging, Pulsed... · Radiology
Jul 2016 64d
S-scan
K161238 · LNH System, Nuclear Magnetic... · Radiology
Jul 2016 67d
6200 Ultrasound System and 6250 Ultrasound System
K153277 · IYN System, Imaging, Pulsed... · Radiology
May 2016 174d
MRI Dynamic Analysis Plus
K153039 · LNH System, Nuclear Magnetic... · Radiology
Jan 2016 81d
S-scan
K151668 · LNH System, Nuclear Magnetic... · Radiology
Sep 2015 81d
G-scan Brio
K142421 · LNH System, Nuclear Magnetic... · Radiology
Apr 2015 224d
MYLABSEVEN, MYLABALPHA
K142008 · IYN System, Imaging, Pulsed... · Radiology
Sep 2014 51d
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