FDA Registration
Active
🇺🇸 United States
Radnostix
Reg #: 3034521
·
FEI: 3003350319
·
Expires 2026
Products
7
Proprietary Names
31
Establishment Types
2
Classifications
7
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Registration Details
- Registration Name
- Radnostix
- Registration Number
- 3034521
- FEI Number
- 3003350319
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4137 Commerce Cir
- City
- IDAHO FALLS
- State
- ID
- ZIP
- 83401
- Country
- US
Regulatory Submissions
- 510(k) Number
- K952910
Owner / Operator
- Firm Name
- RADNOSTIX INC.
- Operator Number
- 9045407
- Address
- 4137 COMMERCE CIRCLE, --
- City
- Idaho Falls
- State
- ID
- Postal Code
- 83401
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Phantom, Test-Pattern, Radionuclide | JAR | Class 1 | Radiology | No | 2021-12-03 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2023-09-08 |
| Holder, Syringe, Lead | IWR | Class 1 | Radiology | No | 2023-12-06 |
| Phantom, Flood Source, Nuclear | IYQ | Class 1 | Radiology | No | 2001-04-04 |
| Source, Calibration, Sealed, Nuclear | IXD | Class 1 | Radiology | No | 2009-10-14 |
| Source, Teletherapy, Radionuclide | IWH | Class 1 | Radiology | No | 2009-10-14 |
| System, Rebreathing, Radionuclide | IYT | Class 2 | Radiology | No | 2023-09-08 |
Proprietary Names
BM83 Ruler Series
BMVQC
BM10
Radvent Swirler
Swirler
The RadVent Swirler Nebulizer
The Swirler Nebulizer
The Swirler UltraShield
BM68 Series
BM01 Series
BM05 Series
BMNT57 Series
BM55 Series
BM04 Series
BM83 Line Series
BMCY68 Series
BM22-01
BMSY-057
BM53 Series
BM02 Series
BM07 Series
BMAN68
BM06 Series
BM08 Series
The RadVent Swirler Aerosol System
The Swirler Aerosol System
INIS-SF-X.X-YY-Z Series
RadVent Tru-Fit Mouthpiece
Tru-Fit Mouthpiece
RadVent Tru-Fit Soft Plastic Mouthpiece
Amici Tru-Fit Soft Plastic Mouthpiece
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility