510(k) K254120— SubtleHD-CT (1.x)

Substantially Equivalent

Subtle Medical, Inc.

Clearance details

Applicant: Subtle Medical, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-12-19
Decision date: 2026-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

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