510(k) K123622 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON
| Applicant | Siemens Medical Solutions USA, Inc., Moutain View CA, US |
| Decision | Substantially Equivalent, Dec 5, 2012 |
| Received | Nov 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123622
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 28, 2016 | Siemens Medical Solutions USA, Inc. Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113.
Radiology:
The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Card Terminated |
IYN | None listed |
| Apr 8, 2016 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M.
Model number: 10433816. Terminated |
IYN | None listed |
| Oct 30, 2015 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 ultrasound systems
model 10433816
Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes. Terminated |
IYN | None listed |
| Sep 17, 2015 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 Ultrasound System with software versions VB10B and lower;
Model 10433816;
Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-na Terminated |
IYN | None listed |
| May 6, 2015 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816.
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and F Terminated |
IYN | None listed |
| May 5, 2015 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816.
Product Usage:
The SC2000 ultrasound imaging system is intended for the following applicat Terminated |
IYO | None listed |
| Feb 5, 2015 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2.
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Ped Terminated |
IYN | None listed |
| May 28, 2014 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. Terminated |
IYN | None listed |
| May 28, 2014 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system. Terminated |
IYN | None listed |
| Jan 24, 2014 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 Ultrasound System;
Power Input: 100-240VAC, 1600W Max, 50/60 Hz.
Manufacturer:
Siemens Medical Solutions USA, Inc.
685 East Middlefield Road
Mountain View, CA 94043
SC2000 ultrasound i Terminated |
IYN | None listed |
| Jan 24, 2014 | Siemens Medical Solutions USA, Inc. ACUSON SC2000
Power Input: 100-240VAC, 1600 Max 50/60Hz;
Siemens Medical Solutions USA, Inc.
685 East Middlefield Road
Mountain View, CA 94043
Ultrasound imaging system. Terminated |
IYN | None listed |
| Oct 23, 2013 | Siemens Medical Solutions USA, Inc. Acuson SC2000 volume imaging ultrasound systems at software version 3.0.
Mfg name:
Siemens Medical Solutions USA, Inc.
Mountain View, CA 94043
Medical Device for human use. Ultrasound imaging system Terminated |
IYN | None listed |
| Apr 10, 2013 | Siemens Medical Solutions USA, Inc. Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200;
The SC2000 ultrasound imaging system is intended for the following applicati Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.