FDA device listing
BONZAI,CT MINI,Djinn Beetle,DJINN BEETLE,Djinn Mammo,Djinn Tonix,DMR,GAIA INTERVENTIONAL GENERATOR,Jedi,Jedi 100 VASC…
FDA device listing 1713693862 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | BONZAI,CT MINI,Djinn Beetle,DJINN BEETLE,Djinn Mammo,Djinn Tonix,DMR,GAIA INTERVENTIONAL GENERATOR,Jedi,Jedi 100 VASC 1,JEDI 100 VASC 1T,Jedi 42 CT,Jedi42CT,Jedi 50 Plus R1T,Jedi 50 R 1T,Jedi50R1T,Jedi 60 CT,Jedi60CT,Jedi 60 DC,Jedi 60DC,JEDI 60 DC,Jedi 60DC Lite,Jedi 60 DC LITE,JEDI 60 DC LITE,Jedi 80 R 1T,Jedi80R1T,Jedi 80 RD 1T,Jedi 80 RF 1T,Jedi80RF1T,JEDI 80 RF1T,Jedi 80 RF 2T,Jedi80RF2T,JEDI… |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Product codes | IZO |
| Device names | IZO - Generator, High-Voltage, X-Ray, Diagnostic |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.1700 |
| Review panels | Radiology |
| Registered establishments | GE BE PRIVATE LIMITED, GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V., GE MEDICAL SYSTEMS SCS, GE Medical Systems Ultrasound & Primary Care Diagnostics LLC, WIPRO GE HEALTHCARE PRIVATE LTD |
| Establishment registrations | 2183066, 9611343, 9613936, 9616047, 9617766 |
| FEI numbers | 2183066, 1000284313, 1000571342, 3002874382, 3003377038 |
| 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