Medical Device Manufacturer · US , Indianapolis , IN

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

20 submissions · 20 cleared · Since 1997

Recent clearances: TECHNOS MP, MODEL AU6, AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION), E-SCAN XQ

Total

Cleared

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.

Biosound Esaote, Inc. is one of 5563 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Biosound Esaote, Inc.

20 devices

1-12 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...

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

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

FDA 510(k) Regulatory Record - Biosound Esaote, Inc.

Filters