# Annalise-Ai Pty, Ltd.

- Location (FDA's records): Sydney, AU
- FDA decisions: 8 (2022–2025): 8 510(k) clearances
- Names in FDA's records: Annalise-Ai Pty , Ltd. (6); Annalise-Ai (2)
- Product codes: QFM (4), QAS (4)
- 510(k) review time since 2016: median 126 days, against 99 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nines, Inc.: 1 (https://510kreport.com/company/nines)
- Behold.Ai Technologies Limited: 1 (https://510kreport.com/company/behold-ai-technologies)
- Aidoc Medical, Ltd.: 1 (https://510kreport.com/company/aidoc-medical)
- Infervision Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/infervision-medical-technology)

## Firms that cite its devices most
- A2z Radiology Ai, Inc.: 1 (https://510kreport.com/company/a2z-radiology-ai)

## Its most-cited devices
- K213941: Annalise Enterprise CXR Triage Pneumothorax (2022), cited by 2
- K223240: Annalise Enterprise CTB Triage Trauma (2023), cited by 2
- K222179: Annalise Enterprise CXR Triage Trauma (2023), cited by 1

## Recent decisions
- K250831: Annalise Enterprise (Apr 23, 2025)
- K231384: Annalise Enterprise CTB Triage Trauma (Sep 22, 2023)
- K231767: Annalise Enterprise CTB Triage Trauma (Sep 22, 2023)
- K231094: Annalise Enterprise CTB Triage-OH (Aug 15, 2023)
- K223240: Annalise Enterprise CTB Triage Trauma (Apr 3, 2023)
- K222179: Annalise Enterprise CXR Triage Trauma (Mar 28, 2023)
- K222268: Annalise Enterprise CXR Triage Trauma (Mar 28, 2023)
- K213941: Annalise Enterprise CXR Triage Pneumothorax (Feb 24, 2022)

Source page: https://510kreport.com/company/annalise-ai