SubtleHD-CT (1.x)— 510(k) K254120
Substantially EquivalentSubtle Medical, Inc.
FDA 510(k) clearance K254120 for SubtleHD-CT (1.x), Substantially Equivalent on 2026-05-15. Applicant: Subtle Medical, Inc.. Device class: 2.
Summary
Subtle Medical's SubtleHD-CT, listed as 1.x, is filed under QIH, automated radiological image processing software.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Subtle Medical filed from Menlo Park, California. The decision came 147 calendar days after receipt (December 19, 2025 to May 15, 2026).
Clearance details
- Applicant
- Subtle Medical, Inc.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code QIH
view allMore clearances from Subtle Medical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.