Acuson Corp.
Mountain View, CA, US
Acuson Corp. appears in FDA device records in Mountain View, CA. FDA records list 37 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 37
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 37 510(k) clearances for Acuson Corp. between 1988 and 2002. The busiest year on record is 1991, with 6. The most recent is 2002, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 3 |
| 1989 | 4 |
| 1990 | 2 |
| 1991 | 6 |
| 1992 | 4 |
| 1993 | 1 |
| 1994 | 4 |
| 1995 | 2 |
| 1997 | 2 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K023772 | KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | LLZ | Substantially Equivalent | |
| K022896 | CSV12 SOFTWARE VIEWER | LLZ | Substantially Equivalent | |
| K022567 | SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K021497 | CYPRESS ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K010950 | CYPRESS SYSTEM | IYO | Substantially Equivalent | |
| K002807 | 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING | IYO | Substantially Equivalent | |
| K992631 | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER | DQO | Substantially Equivalent | |
| K992580 | FETAL ASSESSMENT CAP | IYO | Substantially Equivalent | |
| K991805 | ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION | IYN | Substantially Equivalent | |
| K973767 | HARMONIC IMAGING WITH CONTRAST | IYO | Substantially Equivalent | |
| K973079 | L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K942296 | V5M | ITX | Substantially Equivalent | |
| K935595 | ACUSON MODEL 3001 | ITX | Substantially Equivalent | |
| K930964 | ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) | IYO | Substantially Equivalent | |
| K934915 | ACUSON MODEL 2001 | IYN | Substantially Equivalent | |
| K940285 | ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION | IYN | Substantially Equivalent | |
| K933663 | MODIFICATION OF ACUSON V510B TRANSDUCER | ITX | Substantially Equivalent | |
| K920882 | ACUSON V714 TRANSDUCER | ITX | Substantially Equivalent | |
| K921341 | ACUSON V714OR TRANSDUCER | ITX | Substantially Equivalent | |
| K902515 | ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP | ITX | Substantially Equivalent | |
| K921670 | ACUSON IMAGE MANAGEMENT SYSTEM | IYO | Substantially Equivalent | |
| K911916 | ACUSON C366 TRANSDUCER | ITX | Substantially Equivalent | |
| K911767 | ACUSON V510 TRANSDUCER | ITX | Substantially Equivalent | |
| K904600 | L582 TRANSDUCER | MAA | Substantially Equivalent | |
| K905456 | L328 TRANSDUCER | MAA | Substantially Equivalent | |
| K904951 | S5192R TRANSDUCER | MAA | Substantially Equivalent | |
| K904459 | C544 TRANSDUCER | ITX | Substantially Equivalent | |
| K903561 | QUICK-CLIP NEEDLE GUIDE | ITX | Substantially Equivalent | |
| K900560 | ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE | DQC | Substantially Equivalent | |
| K897151 | ACUSON V328 AND C5432 TRANSDUCERS | JTX | Substantially Equivalent | |
| K890275 | ACUSON S328 TRANSDUCER FOR FETAL CARDIAC PULSED | IYO | Substantially Equivalent | |
| K884271 | ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER | IYO | Substantially Equivalent | |
| K890055 | ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER | IYN | Substantially Equivalent | |
| K884632 | ACUSON I5100 ULTRASOUND TRANSDUCER | IYO | Substantially Equivalent | |
| K883752 | ACUSON L538 TRANSDUCER | IYO | Substantially Equivalent | |
| K882737 | ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER | IYN | Substantially Equivalent | |
| K882549 | ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. | FCG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FCGBiopsy Needle
- DQOCatheter, Intravascular, Diagnostic
- MAAMonitor, Fetal Doppler Ultrasound
- DQCPhonocardiograph
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
- JTXTransport Systems, Anaerobic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain