FDA device listing
Acuson S1000 Diagnostic Ultrasound System,Acuson S2000 Diagnostic Ultrasound System,Acuson S3000 Diagnostic Ultrasound…
FDA device listing 2044106893 · SIEMENS MEDICAL SOLUTIONS USA, INC.
Key facts
| Proprietary names | Acuson S1000 Diagnostic Ultrasound System,Acuson S2000 Diagnostic Ultrasound System,Acuson S3000 Diagnostic Ultrasound System |
|---|---|
| Owner/operator | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Owner/operator number | 9002915 |
| Premarket submissions | K163635 |
| Product codes | ITX, IYN, IYO, OBJ |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, OBJ - Catheter, Ultrasound, Intravascular |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1200, 892.1550, 892.1560, 892.1570 |
| Review panels | Cardiovascular, Radiology |
| Registered establishments | Siemens Healthineers Ltd. |
| Establishment registrations | 3006985147 |
| FEI numbers | 3006985147 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database