FDA device listing
GE Innova 3131 Cath,GE Innova IGS 530 Cath Angio
FDA device listing 2052435085 · Block Imaging SAS
Key facts
| Proprietary names | GE Innova 3131 Cath,GE Innova IGS 530 Cath Angio |
|---|---|
| Owner/operator | Block Imaging SAS |
| Owner/operator number | 10086857 |
| Premarket submissions | K122457 |
| Product codes | IZI, JAA, OWB |
| Device names | IZI - System, X-Ray, Angiographic, JAA - System, X-Ray, Fluoroscopic, Image-Intensified, OWB - Interventional Fluoroscopic X-Ray System |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1600, 892.1650 |
| Review panels | Radiology |
| Registered establishments | BLOCK IMAGING SAS |
| Establishment registrations | 3023003446 |
| FEI numbers | 3023003446 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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