510(k) K132804 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON S1000 / S2000 / S3000
| Applicant | Siemens Medical Solutions USA, Inc. Ultrasound Gro, Moutain View CA, US |
| Decision | Substantially Equivalent, Oct 24, 2013 |
| Received | Sep 6, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132804
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2015 | Siemens Medical Solutions USA, Inc. ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option;
Model numbers:
10041461, 10440017 -S2000 system
10441730 -S3000 system
VTIQ Option- 10439521 and 10439522
Radiology: Terminated |
IYN | None listed |
| Jul 29, 2015 | Siemens Medical Solutions USA, Inc. ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1.
Model numbers:
10041461, 10440017 S 2000 system
10441730 S 3000 system
10441701 S 1000 sy Terminated |
IYN | None listed |
| Jul 1, 2014 | Siemens Medical Solutions USA, Inc. ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems. Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.