FDA Device Establishments · JSON-LD · Markdown
FEI 3034396442 · Manufacture Medical Device · Status: Active
| FEI Number | 3034396442 |
|---|---|
| Owner / Operator | Harrison-AI Medical Pty Ltd (#10085806) |
| Address | Aneja Towers, 4th Floor Block A, Plot 4 & 5 Developed Plot Estate, OMR Perungudi, Chennai Tamil Nadu, 600096, IN |
| Mandatory US Agent | Qserve Group US Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | QAS, QFM |
| Regulation § (21 CFR) | 892.2080 |
| Proprietary names | Annalise Enterprise CXR; Annalise Triage CXR; Annalise Enterprise; Annalise Critical Care AI; Annalise Critical Care AI - Pleural Effusion; Annalise Triage; Annalise - Pleural Effusion; Annalise Enterprise (US); Annalise Enterprise CXR Triage; Annalise Enterprise CXR Triage Trauma |
Source: openFDA. Public-domain (CC0).