FDA device listing
Innova 2100-IQ,Innova 2121-IQ,Innova 3100-IQ,Innova 3131-IQ,Innova 4100-IQ,INNOVA IGS 520,INNOVA IGS 530,INNOVA IGS…
FDA device listing 1155638880 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | Innova 2100-IQ,Innova 2121-IQ,Innova 3100-IQ,Innova 3131-IQ,Innova 4100-IQ,INNOVA IGS 520,INNOVA IGS 530,INNOVA IGS 540,INNOVA IGS 620,INNOVA IGS 630,Integrated Innova - s5i system option,Optima CL320i,Optima CL323i |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K111209 |
| Product codes | IZI |
| Device names | IZI - System, X-Ray, Angiographic |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1600 |
| Review panels | Radiology |
| Registered establishments | GE MEDICAL SYSTEMS SCS |
| Establishment registrations | 9611343 |
| FEI numbers | 1000284313 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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