K242292
- 510(k) number
- K242292
- Device name
- uAI Easy Triage ICH
- Applicant
- Shanghai United Imaging Intelligence Co., Ltd. CN
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2024-09-24
- Date received
- 2024-08-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K242292.pdf
Official FDA record: K242292
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.