SubtleHD (1.x)— 510(k) K243250

Substantially Equivalent

Subtle Medical, Inc.

FDA 510(k) clearance K243250 for SubtleHD (1.x), Substantially Equivalent on 2025-02-12. Applicant: Subtle Medical, Inc..

Clearance details

Applicant: Subtle Medical, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2024-10-15
Decision date: 2025-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

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