ACUSON S1000 / S2000 / S3000
FDA 510(k) clearance K132804 · decided 2013-10-24
Clearance details
- K-number
- K132804
- Device name
- ACUSON S1000 / S2000 / S3000
- Applicant
- Siemens Medical Solutions USA, Inc. Ultrasound Gro
- Decision
- Substantially Equivalent
- Date received
- 2013-09-06
- Decision date
- 2013-10-24
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Moutain View, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model n recall (Z-2321-2015) | Siemens Medical Solutions USA, Inc. | 2015-07-30 |
| ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3 recall (Z-2314-2015) | Siemens Medical Solutions USA, Inc. | 2015-07-29 |
| ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3 recall (Z-1962-2014) | Siemens Medical Solutions USA, Inc. | 2014-07-01 |