K250288

Substantially Equivalent

TeraRecon Cardiovascular.Calcification.CT

Applicant: Terarecon,Inc.
Product 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

Download summary PDF View on FDA.gov ↗

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