Company ยท US
Acuson Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2002. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 11 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 10 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 7 |
| MAA | Monitor, Fetal Doppler Ultrasound | 3 |
| LLZ | System, Image Processing, Radiological | 2 |
| DQC | Phonocardiograph | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| FCG | Biopsy Needle | 1 |
| JTX | Transport Systems, Anaerobic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 22, 2002 | K023772 | KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Acuson Corp. | LLZ |
| Oct 3, 2002 | K022896 | CSV12 SOFTWARE VIEWER Acuson Corp. | LLZ |
| Aug 13, 2002 | K022567 | SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM Acuson Corp. | IYN |
| Jul 9, 2002 | K021497 | CYPRESS ULTRASOUND SYSTEM Acuson Corp. | IYN |
| Jun 27, 2001 | K010950 | CYPRESS SYSTEM Acuson Corp. | IYO |
| Dec 1, 2000 | K002807 | 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING Acuson Corp. | IYO |
| Dec 15, 1999 | K992631 | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER Acuson Corp. | DQO |
| Oct 18, 1999 | K992580 | FETAL ASSESSMENT CAP Acuson Corp. | IYO |
| Aug 2, 1999 | K991805 | ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION Acuson Corp. | IYN |
| Dec 23, 1997 | K973767 | HARMONIC IMAGING WITH CONTRAST Acuson Corp. | IYO |
| Nov 5, 1997 | K973079 | L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM Acuson Corp. | ITX |
| Mar 2, 1995 | K942296 | V5M Acuson Corp. | ITX |
| Mar 2, 1995 | K935595 | ACUSON MODEL 3001 Acuson Corp. | ITX |
| Oct 26, 1994 | K930964 | ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) Acuson Corp. | IYO |
| Oct 21, 1994 | K934915 | ACUSON MODEL 2001 Acuson Corp. | IYN |
| Apr 29, 1994 | K940285 | ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION Acuson Corp. | IYN |
| Jan 21, 1994 | K933663 | MODIFICATION OF ACUSON V510B TRANSDUCER Acuson Corp. | ITX |
| Mar 26, 1993 | K920882 | ACUSON V714 TRANSDUCER Acuson Corp. | ITX |
| Nov 27, 1992 | K921341 | ACUSON V714OR TRANSDUCER Acuson Corp. | ITX |
| Sep 4, 1992 | K902515 | ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP Acuson Corp. | ITX |
| Jun 25, 1992 | K921670 | ACUSON IMAGE MANAGEMENT SYSTEM Acuson Corp. | IYO |
| Jun 18, 1992 | K911916 | ACUSON C366 TRANSDUCER Acuson Corp. | ITX |
| Oct 31, 1991 | K911767 | ACUSON V510 TRANSDUCER Acuson Corp. | ITX |
| Jun 24, 1991 | K904600 | L582 TRANSDUCER Acuson Corp. | MAA |
| May 28, 1991 | K905456 | L328 TRANSDUCER Acuson Corp. | MAA |
| Apr 29, 1991 | K904951 | S5192R TRANSDUCER Acuson Corp. | MAA |
| Mar 29, 1991 | K904459 | C544 TRANSDUCER Acuson Corp. | ITX |
| Mar 5, 1991 | K903561 | QUICK-CLIP NEEDLE GUIDE Acuson Corp. | ITX |
| Dec 3, 1990 | K900560 | ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE Acuson Corp. | DQC |
| Jul 3, 1990 | K897151 | ACUSON V328 AND C5432 TRANSDUCERS Acuson Corp. | JTX |
| Jul 31, 1989 | K890275 | ACUSON S328 TRANSDUCER FOR FETAL CARDIAC PULSED Acuson Corp. | IYO |
| Jul 27, 1989 | K884271 | ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER Acuson Corp. | IYO |
| May 16, 1989 | K890055 | ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER Acuson Corp. | IYN |
| Jan 13, 1989 | K884632 | ACUSON I5100 ULTRASOUND TRANSDUCER Acuson Corp. | IYO |
| Dec 1, 1988 | K883752 | ACUSON L538 TRANSDUCER Acuson Corp. | IYO |
| Sep 8, 1988 | K882737 | ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER Acuson Corp. | IYN |
| Jul 21, 1988 | K882549 | ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. Acuson Corp. | FCG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||