K261465
- 510(k) number
- K261465
- Device name
- INDIRA CLOUD VIEWER
- Applicant
- INDIGO TECHNOLOGIES CO
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2026-07-06
- Date received
- 2026-05-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K261465.pdf
Official FDA record: K261465
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.