CARDIUS 3 X-ACT— 510(k) K083649

Substantially Equivalent

Digirad Corp.

FDA 510(k) clearance K083649 for CARDIUS 3 X-ACT, Substantially Equivalent on 2009-03-09. Applicant: Digirad Corp.. Device class: 2.

Clearance details

Applicant: Digirad Corp.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2008-12-09
Decision date: 2009-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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