510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Esaote North America, Inc

Fishers, IN, US

Esaote North America, Inc appears in FDA device records in Fishers, IN. FDA records list 20 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
20
PMA records
0
Recall records
5
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Esaote North America, Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Biosound Esaote, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 20 510(k) clearances for Esaote North America, Inc between 1997 and 2003. The busiest year on record is 1998, with 6. The most recent is 2003, with 1.

Clearances by year, as a table
510(k) clearance decisions for Esaote North America, Inc, by decision year
YearClearances
19972
19986
19992
20004
20013
20022
20031
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K023255TECHNOS MP, MODEL AU6IYNSubstantially Equivalent
K014168AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)IYNSubstantially Equivalent
K020164E-SCAN XQLNHSubstantially Equivalent
K012728E-SCAN MRI SYSTEMMOSSubstantially Equivalent
K0104057230 ULTRASOUND IMAGING SYSTEM WITH TEIIYNSubstantially Equivalent
K010057MODIFICATION TO ARTOSCAN MLNHSubstantially Equivalent
K001894MODIFICATION TO E-SCANLNHSubstantially Equivalent
K000931AU5 ULTRASOUND IMAGING SYSTEMIYNSubstantially Equivalent
K000681AU5, AU6IYOSubstantially Equivalent
K9943697250 (MEGAS)IYNSubstantially Equivalent
K990968E-SCANLNHSubstantially Equivalent
K990360AU6IYNSubstantially Equivalent
K9824447250 ULTRASOUND IMAGING SYSTEMIYOSubstantially Equivalent
K980468AU5 ULTRASOUND IMAGING SYSTEMIYNSubstantially Equivalent
K981358ARTOSCAN SLHNSubstantially Equivalent
K9812937200 ULTRASOUND IMAGING SYSTEMIYOSubstantially Equivalent
K973922ARCHIMED 4210 AND 4220LOSSubstantially Equivalent
K974079FORMULA FOR ARCHIMEDDPSSubstantially Equivalent
K971942SLED, FINGER, HANDLEITXSubstantially Equivalent
K970703GALILEO HALLEYGWQSubstantially Equivalent

Registered establishments

FDA registered establishments for Esaote North America, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
18265551826555Esaote North America, Inc11907 Exit Five Parkway, Fishers, IN 46037 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2167-2014Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imagingUsing the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit.Class IITerminated
Z-1403-05MyLab25 Ultrasound Imaging System; Model 9807300002.Data may be corrupted upon re-opening archived files.Terminated
Z-1402-05MyLab30CV Ultrasound Imaging System; model 9807300001.Data may be corrupted upon re-opening archived files.Terminated
Z-1401-05MyLab30CV Ultrasound Imaging System; model 9807300000.Data may be corrupted upon re-opening archived files.Terminated
Z-0299-03Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250Excessive power output due to a faulty voltage controller.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain