Data / Medical devices / United States / Radnostix
Radnostix: FDA-registered device maker in Idaho Falls, ID, United States, 3 510(k) clearances
Radnostix is registered with the FDA (registration 3034521) in Idaho Falls, ID, United States. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 19, 1997. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034521
- FEI number
- 3003350319
- Address
- 4137 Commerce Cir, Idaho Falls, ID, United States, 83401
- Owner or operator
- RADNOSTIX INC. (9045407)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 4, 2001
- Registered through
- 2026
- Brand names listed
- Amici Tru-Fit Soft Plastic Mouthpiece, BM01 Series, BM02 Series, BM04 Series, BM05 Series, BM06 Series, BM07 Series, BM08 Series and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Holder, Syringe, Lead | IWR | 1 | Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Specification developer | accessdata.fda.gov |
| Phantom, Flood Source, Nuclear | IYQ | 1 | Manufacturer | accessdata.fda.gov |
| Phantom, Test-Pattern, Radionuclide | JAR | 1 | Manufacturer | accessdata.fda.gov |
| Probe, Uptake, Nuclear | IZD | 1 | Specification developer | accessdata.fda.gov |
| Source, Calibration, Sealed, Nuclear | IXD | 1 | Manufacturer | accessdata.fda.gov |
| Source, Teletherapy, Radionuclide | IWH | 1 | Manufacturer | accessdata.fda.gov |
| System, Rebreathing, Radionuclide | IYT | 2 | Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 19, 1997 | K952910 | THE SWIRLER NEBULIZER | CAF | Substantially Equivalent | Amici, Inc. | accessdata.fda.gov |
| November 3, 1995 | K952893 | THE SWIRLER AEROSOL SYSTEM | CAF | Substantially Equivalent | Amici, Inc. | accessdata.fda.gov |
| October 3, 1990 | K903694 | AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE | IYT | Substantially Equivalent | Amici, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Phantom, Test-Pattern, Radionuclide
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Probe, Uptake, Nuclear
- All makers of Source, Calibration, Sealed, Nuclear
- All makers of Tape And Bandage, Adhesive
- All makers of Holder, Syringe, Lead
Updated March 19, 1997. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.