FDA device listing
12L-RS,12S-RS,3Sc-RS,4C-RS,9L-RS,C1-5-RS,IC9B-RS,IC9-RS,RAB2-6-RS,RAB6-RS,RIC5-9A-RS,Voluson Performance 16,Voluson…
FDA device listing 1833596315 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | 12L-RS,12S-RS,3Sc-RS,4C-RS,9L-RS,C1-5-RS,IC9B-RS,IC9-RS,RAB2-6-RS,RAB6-RS,RIC5-9A-RS,Voluson Performance 16,Voluson Performance 18 |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K250543 |
| Product codes | ITX, IYN, IYO, QIH |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, QIH - Automated Radiological Image Processing Software |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1550, 892.1560, 892.1570, 892.2050 |
| Review panels | Radiology |
| Registered establishments | GE Healthcare Austria GmbH & Co OG, GE Healthcare Japan Corporation, GE MEDICAL SYSTEMS (CHINA) CO., LTD., GE PARALLEL DESIGN, INC., GE ULTRASOUND KOREA, LTD., PARALLEL DESIGN SAS, Wipro GE Healthcare Private Ltd., WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED |
| Establishment registrations | 2032350, 8020021, 9612283, 9617277, 9710090, 9710602, 3003594449, 3032109181 |
| FEI numbers | 3002808529, 3003190524, 3003208270, 3003309342, 3003513129, 3003594449, 3004377820, 3032109181 |
| Establishment operations | 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