K233457
- 510(k) number
- K233457
- Device name
- RUS
- Applicant
- Hutom, Inc. KR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-07-12
- Date received
- 2023-10-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233457.pdf
Official FDA record: K233457
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.