K260231
- 510(k) number
- K260231
- Device name
- MiPACS V5 (1.0.0)
- Applicant
- Apryse Software Corp CO · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2026-06-25
- Date received
- 2026-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K260231.pdf
Official FDA record: K260231
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.