FDA device listing
ACUSON Origin Diagnostic Ultrasound System,ACUSON Origin ICE Diagnostic Ultrasound System,ACUSON Sequoia Diagnostic…
FDA device listing 1164816927 · SIEMENS MEDICAL SOLUTIONS USA, INC.
Key facts
| Proprietary names | ACUSON Origin Diagnostic Ultrasound System,ACUSON Origin ICE Diagnostic Ultrasound System,ACUSON Sequoia Diagnostic Ultrasound System,ACUSON Sequoia Select Diagnostic Ultrasound System |
|---|---|
| Owner/operator | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Owner/operator number | 9002915 |
| Premarket submissions | K242523 |
| Product codes | ITX, IYN, IYO, OBJ, OIJ, QIH |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, OBJ - Catheter, Ultrasound, Intravascular, OIJ - Biopsy Needle Guide Kit, QIH - Automated Radiological Image Processing Software |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1200, 892.1550, 892.1560, 892.1570, 892.2050 |
| Review panels | Cardiovascular, Radiology |
| Registered establishments | Siemens Healthcare s.r.o., Siemens Healthineers Ltd., SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Establishment registrations | 3023245, 3002619337, 3006985147, 3014745562 |
| FEI numbers | 3023245, 3002619337, 3006985147, 3014745562 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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