Annalise-Ai Pty , Ltd.: FDA clearances and approvals
Annalise-Ai Pty , Ltd. has 6 FDA 510(k) clearances (first 2023, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time: 149 days. Since 2017 its median was 149 days, against 115 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 6 | 149 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Annalise-Ai Pty , Ltd.'s cleared 510(k)s took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | 4 | 4 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 2 | 2 |
Review panels
- Radiology (6)
Most recent Annalise-Ai Pty , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231767 | Annalise Enterprise CTB Triage Trauma | QAS | 2023-09-22 | 98 |
| K231384 | Annalise Enterprise CTB Triage Trauma | QAS | 2023-09-22 | 133 |
| K231094 | Annalise Enterprise CTB Triage-OH | QAS | 2023-08-15 | 119 |
| K223240 | Annalise Enterprise CTB Triage Trauma | QAS | 2023-04-03 | 165 |
| K222268 | Annalise Enterprise CXR Triage Trauma | QFM | 2023-03-28 | 243 |
| K222179 | Annalise Enterprise CXR Triage Trauma | QFM | 2023-03-28 | 249 |
Recalls
openFDA lists no recalls under a recalling firm named Annalise-Ai Pty , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Annalise-Ai Pty , Ltd. have?
Annalise-Ai Pty , Ltd. has 6 FDA 510(k) clearances (first 2023, latest 2023), across 2 product codes in 1 review panel.
How long does FDA take to clear Annalise-Ai Pty , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Annalise-Ai Pty , Ltd.'s cleared 510(k)s is 149 days. Since 2017: 149 days, versus 115 days for all cleared 510(k)s in the same product codes.
What devices does Annalise-Ai Pty , Ltd. make?
Its most frequent FDA product codes are QAS (Radiological Computer-Assisted Triage And Notification Software, 4); QFM (Radiological Computer-Assisted Prioritization Software For Lesions, 2).
Has Annalise-Ai Pty , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Annalise-Ai Pty , Ltd. Related entities may recall under other names.
Next steps
- See all 6 Annalise-Ai Pty , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QAS, Annalise-Ai Pty , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.