K260116
- 510(k) number
- K260116
- Device name
- CustoMED Viewer
- Applicant
- CustoMED , Ltd. IL
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2026-06-03
- Date received
- 2026-01-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260116.pdf
Official FDA record: K260116
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.