FDA device listing
Captus 3000 Portable Thyroid Uptake and Well System,Captus 3000 Portable Thyroid Uptake System,Captus 3000 Thyroid…
FDA device listing 1615002313 · Mirion Technologies, Inc.
Key facts
| Proprietary names | Captus 3000 Portable Thyroid Uptake and Well System,Captus 3000 Portable Thyroid Uptake System,Captus 3000 Thyroid Uptake and Well System,Captus 3000 Thyroid Uptake System,Captus 4000e Thyroid Uptake and Well Counting System,Captus 4000e Thyroid Uptake System |
|---|---|
| Owner/operator | Mirion Technologies, Inc. |
| Owner/operator number | 10043529 |
| Product codes | IZD |
| Device names | IZD - Probe, Uptake, Nuclear |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.1320 |
| Review panels | Radiology |
| Registered establishments | MIRION TECHNOLOGIES (CAPINTEC), INC |
| Establishment registrations | 2518443 |
| FEI numbers | 2518443 |
| Establishment operations | Manufacturer |
| 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