K254120
- 510(k) number
- K254120
- Device name
- SubtleHD-CT (1.x)
- Applicant
- Subtle Medical, Inc. CA · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-05-15
- Date received
- 2025-12-19
- 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: K254120.pdf
Official FDA record: K254120
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.