K252762
- 510(k) number
- K252762
- Device name
- HALO AP Dx
- Applicant
- Indica Labs, LLC NM · US
- Product code
- QKQ — Digital Pathology Image Viewing And Management Softw
- Decision date
- 2025-11-25
- Date received
- 2025-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252762.pdf
Official FDA record: K252762
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.