TeraRecon Aorta.CT (1.1.0)— 510(k) K243158

Substantially Equivalent

Terarecon,Inc.

FDA 510(k) clearance K243158 for TeraRecon Aorta.CT (1.1.0), Substantially Equivalent on 2025-01-23. Applicant: Terarecon,Inc..

Clearance details

Applicant: Terarecon,Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2024-09-30
Decision date: 2025-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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