FDA device listing
3S-D,PA6-8-D,Probe,RAM3-8,RM14L,RSM5-14,SP10-16-D,Voluson E10,Voluson E6,Voluson E8,Voluson E8 Expert
FDA device listing 1252456979 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | 3S-D,PA6-8-D,Probe,RAM3-8,RM14L,RSM5-14,SP10-16-D,Voluson E10,Voluson E6,Voluson E8,Voluson E8 Expert |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K122327 |
| 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 PARALLEL DESIGN, INC., GE VINGMED ULTRASOUND A/S |
| Establishment registrations | 2032350, 8020021, 9610482, 9612283 |
| FEI numbers | 3002808457, 3002808529, 3003309342, 3004377820 |
| 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