K242624
- 510(k) number
- K242624
- Device name
- Medical Image Post-processing Software (uOmnispace.CT)
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-05-14
- Date received
- 2024-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242624.pdf
Official FDA record: K242624
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.