FDA device listing
12L-RS,12S-RS,3Sc-RS,6S-RS,6Tc-RS,8C-RS,9L-RS,C1-5-RS,C2-9-RS,E8C-RS,L10-22-RS,L12n-RS,L4-12t-RS,L4-20t-RS,L8-18i-RS,M5S…
FDA device listing 1846202890 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | 12L-RS,12S-RS,3Sc-RS,6S-RS,6Tc-RS,8C-RS,9L-RS,C1-5-RS,C2-9-RS,E8C-RS,L10-22-RS,L12n-RS,L4-12t-RS,L4-20t-RS,L8-18i-RS,M5Sc-RS,ML6-15-RS,Venue,Venue Fit,Venue Go,Venue Sprint |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K251322 |
| Product codes | ITX, IYN, IYO |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1550, 892.1560, 892.1570 |
| Review panels | Radiology |
| Registered establishments | GE Healthcare Austria GmbH & Co OG, GE Healthcare Japan Corporation, GE MEDICAL SYSTEMS (CHINA) CO., LTD., GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V., GE Medical Systems, Israel Ltd., GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC, GE Medical Systems Ultrasound & Primary Care Diagnostics LLC, GE PARALLEL DESIGN, INC., GE VINGMED ULTRASOUND A/S, PARALLEL DESIGN SAS, Wipro GE Healthcare Private Ltd., WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED |
| Establishment registrations | 2032350, 8020021, 9610482, 9612283, 9615849, 9617277, 9710602, 3002183074, 3003594449, 3008729547, 3032008018, 3032109181 |
| FEI numbers | 3002183074, 3002808457, 3002808529, 3002973981, 3003190524, 3003309342, 3003513129, 3003594449, 3004377820, 3008729547, 3032008018, 3032109181 |
| Establishment operations | Manufacturer, Remanufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 10–99 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 10–99 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