Ortho AI— 510(k) K241696

Substantially Equivalent

Ortho Ai, LLC

FDA 510(k) clearance K241696 for Ortho AI, Substantially Equivalent on 2025-01-02. Applicant: Ortho Ai, LLC.

Clearance details

Applicant: Ortho Ai, LLC
Product code: Code QIH
Advisory panel: Radiology
Date received: 2024-06-12
Decision date: 2025-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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