Medical Device Manufacturer · US , Indianapolis , IN

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

39 submissions · 39 cleared · Since 1983
39
Total
39
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biosound, Inc. Radiology
23 devices
1-23 of 23
Cleared Jul 09, 1997
BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER
K971700 · ITX
Radiology · 62d
Cleared Mar 31, 1997
ACCESSPOINT, MED E-MAIL, DICOM READER
K963936 · LMB
Radiology · 181d
Cleared Mar 28, 1997
ARTOSCAN M
K963262 · LNH
Radiology · 220d
Cleared Apr 17, 1996
INTRACAVITY TRANSDUCERS
K953716 · ITX
Radiology · 252d
Cleared Apr 08, 1996
DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A
K953530 · IYO
Radiology · 256d
Cleared Mar 01, 1996
DIAGNOSTIC ULTRASOUND TRANSDUCER
K953759 · ITX
Radiology · 203d
Cleared Mar 01, 1996
DIAGNOSTIC ULTRASOUND TRANDUCER
K953819 · ITX
Radiology · 199d
Cleared Feb 12, 1996
ULTRASOUND PROBE BIOPSY ACCESSORIES
K955458 · ITX
Radiology · 75d
Cleared Feb 02, 1996
TEE PROBE
K953579 · ITX
Radiology · 185d
Cleared Oct 24, 1995
ULTRASOUND PROBE BIOPSY ACCESSORIES
K953430 · ITX
Radiology · 95d
Cleared Sep 18, 1995
LP-12 LAPAROSCOPIC PROBE
K941935 · ITX
Radiology · 516d
Cleared Jun 02, 1995
7050 ULTRASOUND IMAGING SYSTEM
K944287 · ITX
Radiology · 273d
Cleared May 24, 1995
4000 AU ULTRASOUND IMAGING SYSTEM
K944485 · IYO
Radiology · 253d
Cleared Oct 07, 1993
ARTOSCAN
K931022 · LNH
Radiology · 220d
Cleared Jul 02, 1992
LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE
K915860 · ITX
Radiology · 185d
Cleared May 15, 1992
ACCESSORY TO GENESIS III (GCFM)
K913209 · DXK
Radiology · 301d
Cleared Apr 02, 1992
BIPLANE TRANSRECTAL PROBE
K914006 · ITX
Radiology · 206d
Cleared Dec 05, 1991
BIOPSY ACCESSORIES FOR ULTRASOUND PROBES
K912088 · ITX
Radiology · 206d
Cleared Mar 06, 1990
BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM
K895645 · IYO
Radiology · 167d
Cleared Sep 12, 1989
PHASE 2 TRANSCRANIAL PROBE
K894163 · IYN
Radiology · 90d
Cleared Aug 24, 1988
GENESIS II TRANSCRANIAL PROBE
K883238 · IYO
Radiology · 23d
Cleared Dec 30, 1987
EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX
K870899 · ITX
Radiology · 300d
Cleared Apr 04, 1983
BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM
K837063
Radiology · 77d
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