FDA.reportPublic FDA data

Esaote North America, Inc

Matched from indexed company URL: ESA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18265551826555Esaote North America, Inc1Y2026-01-0111907 Exit Five Parkway Fishers IN US 46037
30129814903012981490ESAOTE S.P.A.1N2026-01-01Via degli Olmi 11 Sesto Fiorentino Firenze IT 50019

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
98381980364685K9943697250 (MEGAS)IYN2000-02-24
2008151980364685K9943697250 (MEGAS)IYN2000-02-24
98381594013832K990968E-SCANLNH1999-05-27
98381074653155K9812937200 ULTRASOUND IMAGING SYSTEMIYO1998-06-30
2008151074653155K9812937200 ULTRASOUND IMAGING SYSTEMIYO1998-06-30
98381707073397K974079FORMULA FOR ARCHIMEDDPS1998-01-22
98381383638509K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERITX1997-07-09
2008151383638509K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERITX1997-07-09
98381170686550K260746S-scan Open (100001800)LNH2026-03-27
98381821442607K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)IYN2025-11-25
2008151821442607K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)IYN2025-11-25
98381670937787K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN2026-04-06
2008151670937787K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN2026-04-06
98382031346084K251901Magnifico Open (100009900)LNH2026-03-05
98382024455148K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)IYN2025-06-18
2008152024455148K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)IYN2025-06-18
98381049176802K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN2025-05-16
2008151049176802K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN2025-05-16
98381116205179K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)LNH2024-06-26
98381300593887K2301796440 MyLabX90IYN2023-11-29
2008151300593887K2301796440 MyLabX90IYN2023-11-29
98381651801915K212419Magnifico Open, Magnifico MSKLNH2022-02-04
98381499531629K2120216430 MyLabX75, 6430 MyLab XPro75IYN2021-09-16
2008151499531629K2120216430 MyLabX75, 6430 MyLab XPro75IYN2021-09-16
98381255902897K1921576450 Ultrasound systemIYN2019-11-22
2008151255902897K1921576450 Ultrasound systemIYN2019-11-22
98381136211123K1910727410 Ultrasound System (MyLabSigma)IYN2019-06-10
2008151136211123K1910727410 Ultrasound System (MyLabSigma)IYN2019-06-10
98381751804346K1909896400 Ultrasound System (MyLabX6, MyLabX7)IYN2019-05-10
2008151751804346K1909896400 Ultrasound System (MyLabX6, MyLabX7)IYN2019-05-10
98382032393970K1904477400 Ultrasound SystemsIYN2019-04-01
2008152032393970K1904477400 Ultrasound SystemsIYN2019-04-01
98381145185795K183685O-ScanLNH2019-01-22
98382054491794K1831916420 Ultrasound SystemIYN2018-12-04
2008152054491794K1831916420 Ultrasound SystemIYN2018-12-04
98381999782778K180592G-scan BrioLNH2018-03-30
98381696583916K1732916440 Ultrasound SystemIYN2018-01-12
2008151696583916K1732916440 Ultrasound SystemIYN2018-01-12
98381405349657K1630826200 Ultrasound System and 6250 Ultrasound SystemIYN2017-03-16
2008151405349657K1630826200 Ultrasound System and 6250 Ultrasound SystemIYN2017-03-16
98381864656833K162290MyLabSix CrystaLineIYN2016-10-14
2008151864656833K162290MyLabSix CrystaLineIYN2016-10-14
98381334128476K161973G-scan Brio, S-scanLNH2016-10-25
98381971081509K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemIYN2016-07-19
2008151971081509K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemIYN2016-07-19
98382043312261K161168MyLabSix Ultrasound SystemIYN2016-09-02
2008152043312261K161168MyLabSix Ultrasound SystemIYN2016-09-02
98381114044794K153039MRI Dynamic Analysis PlusLNH2016-01-08
98381565429017K142008MYLABSEVEN, MYLABALPHAIYN2014-09-12
2008151565429017K142008MYLABSEVEN, MYLABALPHAIYN2014-09-12
98381463807627K140677MYLABSSOGNOIYN2014-04-25
2008151463807627K140677MYLABSSOGNOIYN2014-04-25
98381455139582K1339056200 / 6250 ULTRASOUND SYSTEMIYN2014-04-15
2008151455139582K1339056200 / 6250 ULTRASOUND SYSTEMIYN2014-04-15
98381529871986K120748SPEEDUP SOFTWARE OPTIONLNH2012-05-01
98381092035366K120288ORTHOCAD SOFTWARE OPTIONLLZ2012-09-19
98381447452296K110688MYLABGOLDIYO2011-06-02
2008151447452296K110688MYLABGOLDIYO2011-06-02
98381822731516K101605MYLABONE ULTRASOUND SYSTEMIYN2010-08-31
2008151822731516K101605MYLABONE ULTRASOUND SYSTEMIYN2010-08-31
98381203285821K092469O-SCAN MR SYSTEMLNH2009-12-23
98381961212838K091009MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150IYN2009-05-18
2008151961212838K091009MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150IYN2009-05-18
98381044019387K083882MYLABFIVEIYN2009-01-30
2008151044019387K083882MYLABFIVEIYN2009-01-30
98381337912004K081386MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)IYN2008-09-25
2008151337912004K081386MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)IYN2008-09-25
98381281111553K0726533VISEON/SURGERYLLZ2008-01-24
98381431938962K071996MYLAB30, MODEL 7300IYO2007-08-03
2008151431938962K071996MYLAB30, MODEL 7300IYO2007-08-03
98381623472554K070903MYLAB40ITX2007-07-02
2008151623472554K070903MYLAB40ITX2007-07-02
98381032660937K062598IMT.LAB SOFTWARELLZ2006-10-31
2008151032660937K062598IMT.LAB SOFTWARELLZ2006-10-31
98381445776132K061961ART LAB SOFTWARELLZ2006-09-06
2008151445776132K061961ART LAB SOFTWARELLZ2006-09-06
98382024998598K061755MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEMIYO2006-08-07
2008152024998598K061755MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEMIYO2006-08-07
98381720787870K060956G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004LNH2006-05-04
98381896684959K060827MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100IYN2006-05-19
2008151896684959K060827MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100IYN2006-05-19
98381206003248K042236G-SCANLNH2004-10-04
98381648449399K041675PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMSIYN2004-07-23
2008151648449399K041675PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMSIYN2004-07-23
98381497417912K040877ARTOSCAN CLNH2004-05-04
98381744881519K033604TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50LIYO2003-12-15
2008151744881519K033604TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50LIYO2003-12-15
98381910458879K032121MODIFICATION TO E-SCAN XQLNH2003-08-13
98381447554332K023255TECHNOS MP, MODEL AU6IYN2003-02-11
2008151447554332K023255TECHNOS MP, MODEL AU6IYN2003-02-11
98381941492775K02011250S TRINGA ULTRASOUND IMAGING SYSTEMIYO2002-04-19
2008151941492775K02011250S TRINGA ULTRASOUND IMAGING SYSTEMIYO2002-04-19
98381449610573K014168AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)IYN2002-04-25
2008151449610573K014168AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)IYN2002-04-25
98381172364480K012093AETMED IMAGE PROCESSING SOFTWARELLZ2001-09-21
98381915450001K010057MODIFICATION TO ARTOSCAN MLNH2001-02-02
98381804982424K003292260 CORVUSIYO2001-01-05
2008151804982424K003292260 CORVUSIYO2001-01-05
98381507517755K001894MODIFICATION TO E-SCANLNH2000-07-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN602026-04-06
LNH172026-03-27
IYO162011-06-02
LLZ72012-09-19
ITX62007-07-02
DPS11998-01-22

NDC#

PMN#

S-SCAN

2013-12-13

ESAOTE, S.P.A.

S-SCAN

2012-07-09

ESAOTE, S.P.A.

G-SCAN

2011-07-15

ESAOTE, S.P.A.

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