BAC— 510(k) K254131

Substantially Equivalent

DeepHealth, Inc.

FDA 510(k) clearance K254131 for BAC, Substantially Equivalent on 2026-05-21. Applicant: DeepHealth, Inc..

Clearance details

Applicant: DeepHealth, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-12-22
Decision date: 2026-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, MA, US

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