Saige-Density (2.5.0)— 510(k) K243705

Substantially Equivalent

DeepHealth, Inc.

FDA 510(k) clearance K243705 for Saige-Density (2.5.0), Substantially Equivalent on 2024-12-19. 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: 2024-11-29
Decision date: 2024-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Somerville, MA, US

Download summary PDF View on FDA.gov ↗

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