Esaote, S.p.A.
Esaote, S.p.A. holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2026, with 9 FDA device recalls on record.
Top product codes for Esaote, S.p.A.
FDA recalls by Esaote, S.p.A.
- Z-1490-2026 — Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
- Z-3052-2020 — 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 intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)
- Z-3053-2020 — 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 intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)
- Z-0205-2019 — MyLab Gamma, Model 7410
- Z-0206-2019 — MyLab Seven, Model 6400
- Z-0204-2019 — MyLab Alpha, Model 7400
- Z-1138-2018 — 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
- Z-1137-2018 — MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
- Z-2124-2016 — Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Esaote, S.p.A.
- K261331 — I-Genius (100019400)
- K253288 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
- K260746 — S-scan Open (100001800)
- K251901 — Magnifico Open (100009900)
- K253310 — 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
- K243253 — 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
- K241671 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
- K241133 — Magnifico Open (100009900); Magnifico MSK ( 100009910)
- K230179 — 6440 MyLabX90
- K212419 — Magnifico Open, Magnifico MSK
- K212021 — 6430 MyLabX75, 6430 MyLab XPro75
- K192157 — 6450 Ultrasound system
- K191072 — 7410 Ultrasound System (MyLabSigma)
- K190989 — 6400 Ultrasound System (MyLabX6, MyLabX7)
- K183685 — O-Scan
- K183191 — 6420 Ultrasound System
- K180592 — G-scan Brio
- K173291 — 6440 Ultrasound System
- K163082 — 6200 Ultrasound System and 6250 Ultrasound System
- K161973 — G-scan Brio, S-scan
- K162290 — MyLabSix CrystaLine
- K161359 — 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
- K161238 — S-scan
- K153277 — 6200 Ultrasound System and 6250 Ultrasound System
- K153039 — MRI Dynamic Analysis Plus
- K151668 — S-scan
- K142421 — G-scan Brio
- K142008 — MYLABSEVEN, MYLABALPHA
- K142077 — MYLABGAMMA
- K140677 — MYLABSSOGNO
- K133905 — 6200 / 6250 ULTRASOUND SYSTEM
- K133490 — G-SCAN BRIO
- K131996 — S-SCAN
- K132466 — MYLABSEVEN 6400, MYLABALPHA 7400
- K132231 — MYLABSEVEN, MYLABALPHA
- K120288 — ORTHOCAD SOFTWARE OPTION
- K122006 — G-SCAN BRIO
- K121650 — S-SCAN
- K121384 — MYLABSOGNO
- K120748 — SPEEDUP SOFTWARE OPTION
- K111302 — MYLABSEVEN, MYLABALPHA
- K111803 — G-SCAN
- K110802 — A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18
- K110373 — TEMPOROMANIBULAR COIL 15
- K110238 — G-SCAN
- K103152 — 6250 ULTRASOUND SYTEMS
- K100931 — MYLABTWICE, MODEL 6200
- K100670 — S-SCAN, MODEL 9800020010
- K092469 — O-SCAN MR SYSTEM
- K091009 — MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150
- K081386 — MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
- K081794 — MODEL 7340 ULTRASOUND SYSTEM
- K080968 — S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA
- K071996 — MYLAB30, MODEL 7300
- K063207 — S-SCAN MRI SYSTEM
- K061429 — DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA
- K060827 — MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100
- K060956 — G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004
- K052805 — MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150
- K052077 — G-SCAN CERVICAL SPINE COIL
- K051837 — MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100
- K051308 — MYLAB 70 ULTRASOUND IMAGING SYSTEM
- K050326 — 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
- K042236 — G-SCAN
- K041145 — MODIFICATION TO E-SCAN XQ MRI SYSTEM
- K040877 — ARTOSCAN C
- K040596 — ULTRASOUND IMAGING SYSTEM, MODEL 7300
- K032121 — MODIFICATION TO E-SCAN XQ
Data sourced from openFDA. This site is unofficial and independent of the FDA.