510(k) K261795 ยท QIH Automated Radiological Image Processing Software
Quicktome Software Suite
| Applicant | Omniscient Neurotechnology Pty, Ltd., Haymarket, AU |
| Decision | Substantially Equivalent, Sep 10, 2026 |
| Received | May 29, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261795
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.