FDA device listing
HELIOS Collimator,LU50090,Lunar iDXA series Collimator Assembly,OEC Beam Limiting Device,Prodigy/DPX Series Collimator…
FDA device listing 1350778011 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | HELIOS Collimator,LU50090,Lunar iDXA series Collimator Assembly,OEC Beam Limiting Device,Prodigy/DPX Series Collimator Assembly,Wolverine Collimator,X-Ray Collimator |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Product codes | IZW |
| Device names | IZW - Collimator, Automatic, Radiographic |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1610 |
| Review panels | Radiology |
| Registered establishments | GE HANGWEI MEDICAL SYSTEMS CO., LTD., GE Healthcare (China) Co., Ltd., GE MEDICAL SYSTEMS, LLC, GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V., GE Medical Systems Ultrasound & Primary Care Diagnostics LLC |
| Establishment registrations | 2126677, 2183066, 9613445, 9616047, 3008284470 |
| FEI numbers | 2126677, 2183066, 3002175190, 3003377038, 3008284470 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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