TeraRecon Cardiovascular.Calcification.CT— 510(k) K250288

Substantially Equivalent

Terarecon,Inc.

FDA 510(k) clearance K250288 for TeraRecon Cardiovascular.Calcification.CT, Substantially Equivalent on 2025-10-23. Applicant: Terarecon,Inc..

Clearance details

Applicant: Terarecon,Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-01-31
Decision date: 2025-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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