K233676
- 510(k) number
- K233676
- Device name
- Us2.v2
- Applicant
- Eko.Ai Pte Ltd. D/B/A Us2.Ai SG
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-04-01
- Date received
- 2023-11-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K233676.pdf
Official FDA record: K233676
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.