FDA Device Establishments · JSON-LD · Markdown
FEI 3040678329 · Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3040678329 |
|---|---|
| Owner / Operator | PrimeX Medical Pty Ltd (#10094145) |
| Address | 56 Daglish St, Wembley Western Australia, 6014, AU |
| Mandatory US Agent | Registrar Corp |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OTE |
| Proprietary names | Hologic Selenia Dimensions, GE Senographe Pristina, Siemens MAMMOMAT Revelation, Fujifilm Amulet Innovality ;; ; GE Revolution CT, Siemens SOMATOM Definition Flash, Philips Ingenuity CT; Canon Aquilion Prime ; Hologic Horizon DXA, GE Lunar iDXA GE Healthcare Optima XR646, Discovery XR656; Siemens Healthineers Ysio Max, Multix Impact ; Philips Healthcare DigitalDiagnost C90, ProGrade, Canon Medical; Radrex-i, Ultimax-i (fluoroscopy + X-ray) ; GE Voluson E10, Philips EPIQ 7, Siemens ACUSON Sequoia, Canon Aplio i700 |
Source: openFDA. Public-domain (CC0).