Company ยท AU
Annalise-Ai Pty , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2022 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 23, 2025 | K250831 | Annalise Enterprise Annalise-Ai, AU | QFM |
| Sep 22, 2023 | K231767 | Annalise Enterprise CTB Triage Trauma Annalise-Ai Pty , Ltd., AU | QAS |
| Sep 22, 2023 | K231384 | Annalise Enterprise CTB Triage Trauma Annalise-Ai Pty , Ltd., AU | QAS |
| Aug 15, 2023 | K231094 | Annalise Enterprise CTB Triage-OH Annalise-Ai Pty , Ltd., AU | QAS |
| Apr 3, 2023 | K223240 | Annalise Enterprise CTB Triage Trauma Annalise-Ai Pty , Ltd., AU | QAS |
| Mar 28, 2023 | K222268 | Annalise Enterprise CXR Triage Trauma Annalise-Ai Pty , Ltd., AU | QFM |
| Mar 28, 2023 | K222179 | Annalise Enterprise CXR Triage Trauma Annalise-Ai Pty , Ltd., AU | QFM |
| Feb 24, 2022 | K213941 | Annalise Enterprise CXR Triage Pneumothorax Annalise-Ai, AU | QFM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||