FDA Device Establishments · JSON-LD · Markdown
FEI 3022742930 · Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3022742930 |
|---|---|
| Owner / Operator | Radialis Inc. (#10085216) |
| Address | 290 Munro Street, Suite 1360, Thunder Bay Ontario, P7A 7T1, CA |
| Mandatory US Agent | Pragmatic Compliance dba FDAbasics |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KPS |
| Regulation § (21 CFR) | 892.1200 |
| Proprietary names | Radialis PET Camera; Radialis PET Imager |
Source: openFDA. Public-domain (CC0).