K250039
- 510(k) number
- K250039
- Device name
- HPACS
- Applicant
- Healthhub KR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-10-03
- Date received
- 2025-01-08
- 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: K250039.pdf
Official FDA record: K250039
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.