K240645
- 510(k) number
- K240645
- Device name
- Sonix Health
- Applicant
- Ontact Health Co., Ltd. KR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-11-27
- Date received
- 2024-03-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K240645.pdf
Official FDA record: K240645
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.