BAC— 510(k) K254131

Substantially Equivalent

DeepHealth, Inc.

FDA 510(k) clearance K254131 for BAC, Substantially Equivalent on 2026-05-21. Applicant: DeepHealth, Inc.. Device class: 2.

Clearance details

Applicant: DeepHealth, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-12-22
Decision date: 2026-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from DeepHealth, Inc.

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K243688 — Saige-Dx (3.1.0)2024-12-19
K243705 — Saige-Density (2.5.0)2024-12-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.