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Biosound Esaote, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2167-2014Class IIEsaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular June 26, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K023255TECHNOS MP, MODEL AU6February 11, 2003
K014168AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL April 25, 2002
K020164E-SCAN XQFebruary 12, 2002
K012728E-SCAN MRI SYSTEMAugust 29, 2001
K0104057230 ULTRASOUND IMAGING SYSTEM WITH TEIMarch 13, 2001
K010057MODIFICATION TO ARTOSCAN MFebruary 2, 2001
K001894MODIFICATION TO E-SCANJuly 6, 2000
K000931AU5 ULTRASOUND IMAGING SYSTEMJune 8, 2000
K000681AU5, AU6May 3, 2000
K9943697250 (MEGAS)February 24, 2000
K990968E-SCANMay 27, 1999
K990360AU6April 30, 1999
K9824447250 ULTRASOUND IMAGING SYSTEMOctober 6, 1998
K980468AU5 ULTRASOUND IMAGING SYSTEMAugust 26, 1998
K981358ARTOSCAN SJuly 13, 1998
K9812937200 ULTRASOUND IMAGING SYSTEMJune 30, 1998
K973922ARCHIMED 4210 AND 4220May 12, 1998
K974079FORMULA FOR ARCHIMEDJanuary 22, 1998
K971942SLED, FINGER, HANDLEJuly 23, 1997
K970703GALILEO HALLEYMay 19, 1997