FDA applicant
Annalise-Ai Pty, Ltd.
FDA records 8 decisions for Annalise-Ai Pty, Ltd. (Sydney, AU) from 2022 to 2025: 8 510(k) clearances. Most are in product codes QFM (Radiological Computer-Assisted Prioritization…) and QAS (Radiological Computer-Assisted Triage And…). Since 2016 its 510(k)s took a median of 126 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Annalise-Ai”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Annalise-Ai Pty, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Annalise-Ai Pty, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report