Medical Device Manufacturer · US , Mountain View , CA

Acuson Corp.

37 submissions · 37 cleared · Since 1988
37
Total
37
Cleared
0
Denied

Acuson Corp. — FDA 510(k) Submissions

Acuson Corp. has submitted 37 FDA 510(k) premarket notifications since 1988, of which 37 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Transducer, Ultrasonic, Diagnostic, System, Imaging, Pulsed Echo, Ultrasonic, System, Imaging, Pulsed Doppler, Ultrasonic, Monitor, Fetal Doppler Ultrasound, System, Image Processing, Radiological . Use the specialty filter in the sidebar to narrow results.

37 devices
1–25 of 37
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K023772 · LLZ System, Image Processing,... · Radiology
Nov 2002 10d
CSV12 SOFTWARE VIEWER
K022896 · LLZ System, Image Processing,... · Radiology
Oct 2002 30d
SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM
K022567 · IYN System, Imaging, Pulsed... · Radiology
Aug 2002 11d
CYPRESS ULTRASOUND SYSTEM
K021497 · IYN System, Imaging, Pulsed... · Radiology
Jul 2002 61d
CYPRESS SYSTEM
K010950 · IYO System, Imaging, Pulsed... · Radiology
Jun 2001 90d
3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING
K002807 · IYO System, Imaging, Pulsed... · Radiology
Dec 2000 84d
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
K992631 · DQO Catheter, Intravascular,... · Radiology
Dec 1999 131d
FETAL ASSESSMENT CAP
K992580 · IYO System, Imaging, Pulsed... · Radiology
Oct 1999 77d
ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION
K991805 · IYN System, Imaging, Pulsed... · Radiology
Aug 1999 68d
HARMONIC IMAGING WITH CONTRAST
K973767 · IYO System, Imaging, Pulsed... · Radiology
Dec 1997 82d
L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM
K973079 · ITX Transducer, Ultrasonic,... · Radiology
Nov 1997 79d
ACUSON MODEL 3001
K935595 · ITX Transducer, Ultrasonic,... · Radiology
Mar 1995 468d
V5M
K942296 · ITX Transducer, Ultrasonic,... · Radiology
Mar 1995 294d
ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)
K930964 · IYO System, Imaging, Pulsed... · Radiology
Oct 1994 609d
ACUSON MODEL 2001
K934915 · IYN System, Imaging, Pulsed... · Radiology
Oct 1994 371d
ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION
K940285 · IYN System, Imaging, Pulsed... · Radiology
Apr 1994 109d
MODIFICATION OF ACUSON V510B TRANSDUCER
K933663 · ITX Transducer, Ultrasonic,... · Radiology
Jan 1994 177d
ACUSON V714 TRANSDUCER
K920882 · ITX Transducer, Ultrasonic,... · Radiology
Mar 1993 394d
ACUSON V714OR TRANSDUCER
K921341 · ITX Transducer, Ultrasonic,... · Radiology
Nov 1992 252d
ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP
K902515 · ITX Transducer, Ultrasonic,... · Radiology
Sep 1992 822d
ACUSON IMAGE MANAGEMENT SYSTEM
K921670 · IYO System, Imaging, Pulsed... · Radiology
Jun 1992 78d
ACUSON C366 TRANSDUCER
K911916 · ITX Transducer, Ultrasonic,... · Radiology
Jun 1992 415d
ACUSON V510 TRANSDUCER
K911767 · ITX Transducer, Ultrasonic,... · Radiology
Oct 1991 195d
L582 TRANSDUCER
K904600 · MAA Monitor, Fetal Doppler... · Radiology
Jun 1991 257d
L328 TRANSDUCER
K905456 · MAA Monitor, Fetal Doppler... · Radiology
May 1991 175d
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