Medical Device Manufacturer · US , Indianapolis , IN

Biosound Esaote, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1997
20
Total
20
Cleared
0
Denied

Biosound Esaote, Inc. has 20 FDA 510(k) cleared radiology devices. Based in Indianapolis, US.

Historical record: 20 cleared submissions from 1997 to 2003.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Biosound Esaote, Inc.
20 devices
1-20 of 20
Cleared Feb 11, 2003
TECHNOS MP, MODEL AU6
K023255 · IYN
Radiology · 134d
Cleared Apr 25, 2002
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING...
K014168 · IYN
Radiology · 127d
Cleared Feb 12, 2002
E-SCAN XQ
K020164 · LNH
Radiology · 26d
Cleared Aug 29, 2001
E-SCAN MRI SYSTEM
K012728 · MOS
Radiology · 14d
Cleared Mar 13, 2001
7230 ULTRASOUND IMAGING SYSTEM WITH TEI
K010405 · IYN
Radiology · 29d
Cleared Feb 02, 2001
MODIFICATION TO ARTOSCAN M
K010057 · LNH
Radiology · 25d
Cleared Jul 06, 2000
MODIFICATION TO E-SCAN
K001894 · LNH
Radiology · 15d
Cleared Jun 08, 2000
AU5 ULTRASOUND IMAGING SYSTEM
K000931 · IYN
Radiology · 78d
Cleared May 03, 2000
AU5, AU6
K000681 · IYO
Radiology · 65d
Cleared Feb 24, 2000
7250 (MEGAS)
K994369 · IYN
Radiology · 59d
Cleared May 27, 1999
E-SCAN
K990968 · LNH
Radiology · 65d
Cleared Apr 30, 1999
AU6
K990360 · IYN
Radiology · 84d
Cleared Oct 06, 1998
7250 ULTRASOUND IMAGING SYSTEM
K982444 · IYO
Radiology · 84d
Cleared Aug 26, 1998
AU5 ULTRASOUND IMAGING SYSTEM
K980468 · IYN
Radiology · 201d
Cleared Jul 13, 1998
ARTOSCAN S
K981358 · LHN
Radiology · 90d
Cleared Jun 30, 1998
7200 ULTRASOUND IMAGING SYSTEM
K981293 · IYO
Radiology · 82d
Cleared May 12, 1998
ARCHIMED 4210 AND 4220
K973922 · LOS
Cardiovascular · 209d
Cleared Jan 22, 1998
FORMULA FOR ARCHIMED
K974079 · DPS
Cardiovascular · 85d
Cleared Jul 23, 1997
SLED, FINGER, HANDLE
K971942 · ITX
Radiology · 57d
Cleared May 19, 1997
GALILEO HALLEY
K970703 · GWQ
Neurology · 82d
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